In order to bring FDA processes in line with ICH guidance and to harmonise technical requirements for registration of marketing approval, the FDA has published this updated guidance on the frequency of submissions and for the content of periodic safety updates. The goal is to bring all three regions (EU, Japan, United States) into harmonisation.
Posted in market access, marketing
Tagged Cliniacl safety, E2C, ICH, periodic reporting
The EOS 2D/3D imaging system is an emerging technology with potentially important clinical benefits. Current evidence shows there are some patient benefits for people with spinal deformities in terms of radiation dose reduction and increased throughput. However, those
benefits alone are insufficient to justify the cost of the system. No clinical evidence was available to quantify the extent of patient benefits from the EOS system’s imaging features including 3D reconstruction, weight-bearing whole-body imaging, and simultaneous posteroanterior (PA) and lateral imaging. Therefore, the EOS 2D/3D imaging system is not currently recommended for routine use in the NHS.
NICE encourages use of the EOS 2D/3D imaging system in specialist research settings to
collect evidence about potentially important clinical benefits associated with 3D reconstruction,
single image weight-bearing whole-body imaging and simultaneous PA and lateral imaging.
The European medicines agency (EMA) has started a review Orilistat containing anti-obesity medicines, there is a concern that rare cases of hepatic injury had impacted on the benefit risk profile of these drugs.
The review will focus on is Xencical well as a number of medicines that are either regulated centrally or nationally. The risk of liver reactions with these drugs has been well-known and kept under tight review.
Full Text Here
The European Medicines Agency has started a review of orlistat-containing anti-obesity medicines, to determine whether the very rare cases of hepatic injury have an impact on their benefit-risk profile and conditions of use.
The review includes the centrally authorised prescription-only medicine Xenical (orlistat 120 mg) and the centrally authorised over-the-counter-medicine Alli (orlistat 60 mg), as well as a number of medicines containing orlistat that have either already or are in the process of being authorised at national level.
The risk of liver reactions with orlistat is well known and had been kept under close review by the Agency’s Committee for Medicinal Products for Human Use (CHMP) since the initial marketing authorisation of these medicines. The risks of liver reactions is reflected in the product information for centrally authorised orlistat-containing medicines and addressed in the risk management plan. The CHMP is currently harmonising the product information for both centrally authorised medicines. The vast majority of reports of liver injury are not serious, and severe liver injury has been reported only very rarely. The new review focuses on the strength of evidence relating to severe liver injury.
The most recently submitted analysis, which covers of cases of hepatic events reported with orlistat 120 mg between 8 August 2009 and 31 January 2011, identified a total of 21 suspected cases of which 4 were cases of severe liver toxicity (one fatal case of hepatic failure, one case of hepatic failure leading to liver transplantation, one case of exacerbation of hepatitis and one case of hepatitis). Overall, between 1997 until January 2011 there were 21 cases of suspected serious liver toxicity for which a causal link to orlistat cannot be excluded, although these cases do not provide strong evidence of a link to orlistat as alternative explanations for liver injury are present in many of the cases. Furthermore, the number of cases needs to be considered in the context of cumulative usage of these medicines in 38 million patients.
During the period between May 2007 and January 2011 there were a total of 9 reports of suspected severe liver injury with orlistat 60 mg, although in some cases other possible explanations for liver injury were present and some cases provided insufficient information to allow assessment. These 9 cases need to be considered in the context of cumulative usage in 11 million patients.
The Committee is now reviewing all relevant data on the risk of hepatotoxicity of orlistat-containing medicines and will issue an opinion on whether or not the marketing authorisations for these medicines should be revoked, suspended or changed.
The European commission is seeking views from the public and industry on a concept paper dealing with the implementation of measures for performance activities related to safety monitoring of medicines. The paper is open for consultation until 7 November and provide technical details of the European medicines agency (EMA) marketing authorisation holders need to apply to their businesses.
Full Text Here
The European Commission is seeking views from the public on a concept paper
on implementing measures for the performance of activities related to the safety monitoring of medicines.
The paper, which is open for consultation until 7 November 2011, provides technical details that the European Medicines Agency, medicines regulatory authorities in European Union (EU) Member States and marketing-authorisation holders will need to apply when implementing the new pharmacovigilance legislation.
The document provides details on:
The Agency and representatives from Member States provided technical expertise to help with the preparation of this document.
The concept paper is available to download from the European Commission’s pages on pharmacovigilance. All comments on the paper should be sent directly to the Commission.
This consultation process is a key step in the implementation of the pharmacovigilance legislation. The Agency is working closely with the European Commission, as well as national medicines regulatory authorities, patients, healthcare professionals and pharmaceutical companies, to ensure the effective implementation of the new legislation.
The launch of this consultation is in line with the target in the implementation plan for the new legislation.
Full Text Here
This guidance has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and is supplementary to the regulatory framework as set out in the Medicines (Advertising) Regulations 1994 (“the Advertising Regulations”, SI 1994/1932 as amended) which implement Titles VIII and VIIIa of European Directive 2001/83/EC. General advice on compliance with the Advertising Regulations is given in the MHRA Blue Guide.
The internet is used widely to provide information to consumers and to promote products and services. This guidance is intended primarily for companies and organisations which do not hold marketing authorisations for medicines but which provide services that may lead to the prescription and supply of a prescription only medicine (POM). The guidance seeks to ensure that the content of such websites does not contravene the Advertising Regulations. In particular, it highlights the prohibition by regulation 7 of the Advertising Regulations of advertisements to the public likely to lead to the use of a POM. It is designed to help advertisers to promote their services without promoting specific POM medicines and thereby coming within the scope of the Advertising Regulations.
If a complaint is received, the decision on whether a particular website complies with the Advertising Regulations will be taken by the MHRA on a case by case basis, having regard to the circumstances of the particular case.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Posted in market access, marketing
Full Text Here
This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-thecounter (OTC) drug monograph system and to describe the process for submitting that information. FDA regulations set forth criteria and procedures by which OTC drugs that initially were marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered for inclusion in the OTC drug monograph system (21 CFR 330.14). The regulations establish a two-part process. First, to determine whether a drug product is eligible to be considered for inclusion in the OTC drug monograph system, certain information must be submitted in a time and extent application (TEA) to show that a drug product can meet the statutory standard of marketing to a material extent and for a material time.2 Second, if the drug product is found eligible to be considered for inclusion in the OTC drug monograph system, we will publish a notice of eligibility in the Federal Register that requests that interested persons submit data to demonstrate the safety and effectiveness of the drug product for its OTC use(s) (21 CFR 330.14(e) and (f)).
This guidance describes the format and content of a TEA that is used to determine if a drug has been marketed OTC to a material extent and for a material time, and what happens after a TEA is submitted. Drug products covered by this guidance are those OTC drug products that: (1) were initially marketed in the United States after the OTC drug review began on May 11, 1972; or (2) are without any U.S. marketing experience.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
This guidance has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and is supplementary to the regulatory framework as set out in the Medicines (Advertising) Regulations 1994 (“the Advertising Regulations”, SI 1994/1932 as amended) which implement Titles VIII and VIIIa of European Directive 2001/83/EC. General advice on compliance with the Advertising Regulations is given in the MHRA Blue Guide.
The internet is used widely to provide information to consumers and to promote products and services. This guidance is intended primarily for companies and organisations which do not hold marketing authorisations for medicines but which provide services that may lead to the prescription and supply of a prescription only medicine (POM). The guidance seeks to ensure that the content of such websites does not contravene the Advertising Regulations. In particular, it highlights the prohibition by regulation 7 of the Advertising Regulations of advertisements to the public likely to lead to the use of a POM. It is designed to help advertisers to promote their services without promoting specific POM medicines and thereby coming within the scope of the Advertising Regulations.
If a complaint is received, the decision on whether a particular website complies with the Advertising Regulations will be taken by the MHRA on a case by case basis, having regard to the circumstances of the particular case.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
This course is designed to provide a firm grounding in key aspects of global clinical pre- and post-marketing safety.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Tagged clinical, marketing, pharmacovigilance, safety
Full Text Here
This event is part of the electronic summary of product characteristics (e-SPC) project which aims to enhance patient safety, drug efficacy and improve pharmacotherapy by making the prescribing process more customised to individual patient’s needs. Registration open until 23/09/2011 by completing and returning the registration form via email.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
Rabeprazole sodium is a substituted benzimidazole gastric proton pump inhibitor (PPI) (ATC Code: A02BC04). Clinical trials have confirmed the efficacy of rabeprazole in the treatment of gastro-oesophageal reflux disease (GORD) including symptomatic relief of heartburn.
The 10mg dose of rabeprazole has been available as a prescription only medicine for Symptomatic GORD with the same posology since 2001 in the UK: Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD): 10mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10mg once daily when needed.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
The Food and Drug Regulations, more specifically sections C.01.016 to C.01.020, and C.08.007 and C.08.008,set forth regulatory requirements for manufacturers, which includes Marketed Authorisation Holders (MAH) and importers, regarding the reporting of adverse drug reactions and the reporting of unusual failures in efficacy of new drugs to Health Canada. As part of Health Canada’s mandate to maximize the safety, quality and efficacy of health products, Health Canada implemented on August 1, 2004, an inspection programme for PMRC. The PMRC inspection program is intended to verify that manufacturers are in compliance with the regulatory requirements including but not limited to, the receipt, analysis and submission of drug safety information to Health Canada, such as the reporting of domestic and foreign adverse drug reactions within 15 days, the preparation of annual summary reports, the maintenance of records related to reports, case reports and unusual failures in efficacy, as well as the reporting of domestic cases of unusual failures in efficacy for new drugs within 15 days.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
The European Medicines Agency has welcomed the new Directive on falsified medicines, published in the Official Journal of the European Union on Friday 1 July.
The new laws aim to prevent falsified medicines entering the legal supply chain and reaching patients. They will do this by introducing harmonised safety and strengthened control measures across Europe, including:
Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. They may contain ingredients of low quality or in the wrong doses, be mislabelled with respect to their identity or source or have fake packaging or the wrong ingredients.
The Agency is working closely with European Commission and its national and international partners on the implementation of this legislation over the next 18 months. The Directive is coming into force on 21 July 2011 and Member States will have to start applying its measures from January 2013.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
Savlon Cold Sore Cream 1% w/w is indicated for the treatment of herpes simplex virus infections of the lips and face (herpes labialis) in adults and children over 12 years of age.
Recurrent herpes simplex labialis is a very common worldwide disease, mostly due to Herpes simplex virus type 1 (HSV-1) with a prevalence of 20-45% in different populations worldwide. The infection is characterised by repeated attacks of encrusted lesions on the lips and around the mouth. Recurrence is a consequence of reactivation of latent virus. Typically, a ‘classical lesion’ begins with the prodromal ‘tingling’ sensation followed by blister, ulcer, then a crust and can take between 5-15 days for resolution. The frequency of attacks can vary between 2 and 10 attacks per year. Although episodes are generally mild in nature, non-serious and self-limiting, the lesion is often painful and disfiguring. The discomfort, cosmetic impact and fear of transmitting the virus to others can lead many sufferers to seek treatment rapidly, with an antiviral medication that can modify the course of infection.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
This guidance is intended for manufacturers who market over-the-counter (OTC) sunscreen drug products without an approved application.2 OTC sunscreens are not yet the subject of an effective final monograph, and we continue to evaluate information relevant to defining conditions under which such products are GRASE and not misbranded. However, OTC sunscreens marketed without approved applications and containing specified active ingredients (see section II of this guidance) are subject to a final rule issued in 2011 that establishes labeling and testing requirements. Several other ongoing and planned rulemaking proceedings also address these products. Because questions may arise about the agency’s expectations in light of these various proceedings, this guidance document describes the Agency’s intended enforcement approach with respect to OTC sunscreen products marketed without approved applications.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens currently sold over-the-counter (OTC) (i.e. non-prescription). These requirements support the Agency’s ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness. The new requirements, as well as several proposed changes for future rules, are outlined in four regulatory documents that include a Final Rule, a Proposed Rule, an Advance Notice of Proposed Rulemaking, and a Draft Guidance for Industry.
The following questions and answers provide a brief overview of the recent regulatory actions and highlight the most important information for consumers to know when buying and using sunscreen products.
Q1. Why is FDA making changes to how sunscreens are marketed in the United States?
Q2. When will these changes take effect?
Q3. What does the SPF value on sunscreen labels indicate?
Q4. Does FDA believe sunscreens are still safe and effective? Do consumers need to throw away the sunscreens they are currently using?
Q5. What do consumers most need to know when buying and using sunscreens?
Q6. What are the main points of the new Final Rule?
Q7. Does the Final Rule apply to cosmetics and moisturizers containing sunscreen?
Q8. What does the Proposed Rule address?
Q9. What is the purpose of the Advance Notice of Proposed Rulemaking (ANPR)?
Q10. Why is the Advance Notice of Proposed Rulemaking (ANPR) requesting additional data on sunscreen products in the form of sprays?
Q11. What is included in the Draft Guidance for Industry?
Q12. Why isn’t FDA finalizing all the proposed sunscreen changes under one rule?
Q13. Where can I find more information on these various regulatory actions?
Q14. Where can I find more information on sunscreen use?
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. FDA anticipates that during an influenza pandemic, industry and FDA workforces may be reduced because of high employee absenteeism, while reporting of adverse events2 related to widespread use of medical products indicated for the treatment or prevention of influenza may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during an influenza pandemic. FDA believes this approach will make it possible for firms with reporting responsibilities to focus their limited resources on the following types of reports:
• reports related to medical products indicated for the treatment or prevention of influenza
• other reports indicated in this guidance
• reports on products presenting special concerns as specified by FDA
This guidance revises the draft guidance of the same title published in December 2008. Once final, this guidance will be considered the FDA’s current thinking regarding postmarketing adverse event reporting during an influenza pandemic.
This guidance is not intended to discourage adverse event reporting during an influenza pandemic by firms that are able to continue reporting operations. In addition, this guidance does not address monitoring and reporting of adverse events that might be imposed as a condition for medical products authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3).3 This guidance also does not address monitoring and reporting of adverse events as required by regulations establishing the conditions for investigational use of drugs, biologics, and devices. (See 21 CFR parts 312 and 812.)
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Posted in manufacturing, marketing
Full Text Here
The European Medicines Agency is working with its European and international regulatory partners to monitor and evaluate the possible risk of radioactive contamination of medicines manufactured in Japan following the radiation leak from the Fukushima Daiichi nuclear power plant.
The exchange of information with the Japanese competent authorities, the Ministry of Health, Labour and Welfare (MHLW) and the Ministry for Agriculture, Forestry and Fisheries (MAFF), as well as with other regulatory partners around the globe, has reassured the Agency that the risk to public and animal health, if any, is very small.
The Agency is taking a precautionary approach that takes into account the measures put in place in the European Union (EU) for food and animal feed.
Marketing authorisation holders (MAHs) are responsible for ensuring the continued quality, safety and efficacy of medicines.
MAHs of medicines wholly or partially manufactured in the Japanese prefectures closest to the power plant (Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Yamagata, Niigata, Nagano, Yamanashi, Saitama, Tokyo and Chiba) are asked to test their products to determine the level of the radionuclides iodine-131, caesium-134 and caesium-137 prior to export from Japan. From the information received from Japanese companies, only a small number of medicines are manufactured in these prefectures and are therefore potentially affected.
This testing is intended as an interim approach, which is likely to be revised based on experience and as initial results become available.
Full Text Here
This guidance document addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the Post-Authorisation phase.
It will be updated regularly to reflect new developments, to include guidance on further post-authorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by “New” or “Rev” upon publication, and their updates will be reflected in the “table of revisions” below.
The Agency emphasises the usefulness of pre-submission dialogue between MAHs and the EMA/(Co-) Rapporteur. The Product Team is available to address any questions MAHs may have regarding a particular upcoming post-authorisation application. Where appropriate, a pre-submission meeting could be organised at the Agency in order to obtain further procedural and regulatory/legal advice.
This guidance information and fruitful pre-submission dialogue between MAHs and the Agency should enable MAHs to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated and processed promptly.
To obtain the information on a certain topic, simply click on the question.
We trust that the information, linked to the question, answers most of your queries.
However, in case of doubt and since applications may have their own particularities not addressed in this document, we strongly encourage MAHs in such cases to contact the Agency in advance of the planned submission.
Where necessary, a pre-submission meeting can be arranged.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension.2 With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction. However, blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem. The Food and Drug Administration (FDA) believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. This guidance recommends standard labeling for antihypertensive drugs except where differences in labeling are supported by clinical data. We encourage applicants to submit labeling supplements containing the new language.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
This guidance has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) in consultation with the homeopathic medicines sector and advertising regulatory bodies. It is intended for advertisers and suppliers of homeopathic medicinal products.
This guidance interprets the legal requirements for advertising of homeopathic medicines to the public and to homeopathic practitioners and recommends best practice to ensure responsible advertising. It is supplementary to the regulatory framework as set out in the Medicines (Advertising) Regulations 1994 (SI 1994/1932 as amended – the Advertising Regulations), which implement Title VIII of European Directive 2001/83/EC.
Further information and general advice on compliance with the Advertising Regulations is available in the MHRA Blue Guide, Advertising and Promotion of medicines in the UK, available on the MHRA website.
On investigation, the decision on whether a particular advertisement complies with the Regulations would be taken by the MHRA on a case by case basis, having regard to the facts of the particular case.
All advertising of homeopathic products or services is subject to the general rules on misleading advertising administered by the Advertising Standards Authority. Further information is available at www.asa.org.uk.
This guidance covers the specific requirements under the medicines legislation for advertising of homeopathic medicines for human use in the UK. Advice is also provided to help ensure that advertising for services which involve the supply of homeopathic products, to practitioners or to the public, does not promote unlicensed homeopathic medicines.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Posted in market access, marketing
BBC Health News