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Consultation ARM 65 seeks your views on the reclassification from POM to P Algopain-eze 140 mg Medicated Plaster. The Reclassification Summary and Patient Information Leaflet as provided by the applicant company are displayed below. Comments should be sent either by post to Veronica Alexander in room 14-138, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ or by email (reclassification@mhra.gsi.gov.uk) to arrive by 25 March 2010. Contributions received after that date cannot be included in the exercise.
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.
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Diabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to defective insulin secretion, insulin action or both. The chronic hyperglycaemia of diabetes mellitus is associated with significant long term sequelae, particularly damage, dysfunction and failure of various organs – especially the kidney, eye, nerves, heart and blood vessels.
Type 1 diabetes is the result of pancreatic beta cell destruction and is prone to acute complications, such as ketoacidosis. In type 1 diabetes the main goal is optimal blood glucose control to be achieved by optimal insulin replacement therapy, extensive education and disease self management. Prevention of complications and management of pregnancy are important issues.
Type 2 diabetes is a complex disorder which involves various degrees of decreased beta-cell function, peripheral insulin resistance and abnormal hepatic glucose metabolism. Glucose control in type 2 diabetes deteriorates progressively over time, and, after failure of diet and exercise alone, needs on average a new intervention with glucose-lowering agents every 3-4 years in order to obtain/retain good control. Despite combination therapy and/or insulin treatment, a sizeable proportion of patients remains poorly controlled.
Overweight, hypertension and hyperlipidaemia are often associated with diabetes mellitus and multiple cardiovascular risk factor intervention is the key issue in type 2 diabetes. Therefore, global treatment aims in management of diabetes mellitus cover both lowering of blood glucose to near normal levels and correcting metabolic abnormalities and cardiovascular risk factors. Indeed, it has been shown that normalisation or near normalisation of glucose levels (assessed by changes in HbA1c) in patients with type 1 and type 2 diabetes significantly reduces the risk of microvascular complications (retinopathy, nephropathy and neuropathy); the macrovascular risk reduction in patients with type 2 diabetes is less certain.
In children and adolescents, the diagnosis of diabetes type 1 and type 2 is similar to that in adults, however, the discrimination between them may not always be straightforward. Type 1 diabetes is the predominant form in children. Type 2 diabetes has been recently emerging among – mostly obese – children in puberty and may present with ketoacidosis as the first manifestation of the disease; an obese adolescent with hyperglycaemia may have either type 1 or type 2 diabetes. An important feature of type 2 diabetes in adolescence is the higher insulin resistance and faster beta cell destruction rate relative to adults.
ADA recommendations for the diagnosis of diabetes in children are based on presence or absence of:
• obesity,
• family history,
• fasting insulin and C-peptide levels,
• auto-antibodies (Diabetes Care, 23(3):381, 2000)
• age of onset
and may help discriminating between type 1 and 2 diabetes in children and adolescents.
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 regulattions, rules and initiatives each month, and summarise 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.
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The current CHMP Note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus CPMP/EWP/1080/00 was adopted by the CHMP in November 2002. New aspects have emerged since then including:
- Paediatric regulation has been implemented and a need for specific trials in children and adolescents with diabetes is considered.
- A number of new medicines for diabetes have been approved.
- Some medicines have only limited long-term safety data and may be associated with an increased cardiovascular risk.
- The possibility to develop medicines for the prevention of diabetes has been proposed.
- Combination treatment studies, especially with insulin, become more and more complex.
Therefore, the points mentioned above may deserve discussion and a need to update the guidance has been identified.
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 regulattions, rules and initiatives each month, and summarise 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.
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This guidance describes for industry the information that FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, under the traditional review process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals. The review clock for the performance review goals begins when the Agency receives a complete submission2 (see sections II. Background and III. PDUFA IV Goal Dates).
Accurate identification of medications is critical to preventing medication errors and potential harm to the public. This guidance is intended to assist industry in the submission of a complete package of information that FDA will use in the assessment of:
1. the safety aspects of a proposed proprietary name, to reduce medication errors, and
2. the promotional implications of a proposed proprietary name, to ensure compliance with other requirements for labeling and promotion using our traditional review methods.
This guidance applies to proprietary name submissions for the following types of products:
• prescription drug products, including biologics, that are the subject of an investigational new drug application (IND), a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA)
• nonprescription drug products that are the subject of an IND, NDA, or ANDA
This guidance does not describe the methods used for evaluation of proposed proprietary names using the traditional review process, nor does the guidance describe the information needed by FDA to evaluate proposed proprietary names under the voluntary 2-year pilot program being conducted by CDER and CBER. That information can be found in the FDA concept paper entitled “PDUFA Pilot Project Proprietary Name Review,” dated September 2008.
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.
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This addendum to the Note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CHMP/EWP 558/95 Rev 1) has been produced in response to recent advances in the development of agents intended for the treatment of disease due to Mycobacterium tuberculosis. Specific guidance was considered to be appropriate due to the differences in approaches to the treatment of tuberculosis compared with the treatment of other types of bacterial infections. In-vitro and in-vivo non-clinical studies can be used to assess the potential efficacy of test agents in various dose and combination regimens for the treatment of drug-susceptible and drug-resistant M. tuberculosis. The data can provide some indication of the extent of exploratory clinical studies that may be needed before selecting one or a few test combination regimens to be evaluated in confirmatory studies of efficacy. If non-clinical studies indicate that an agent may be suitable for the treatment of drug-susceptible and drug-resistant M. tuberculosis clinical studies that investigate each mode of use may be conducted in parallel or in tandem. It is not considered possible to extrapolate a demonstration of efficacy against drug-susceptible M. tuberculosis to the treatment of drug-resistant organisms or vice versa. Each type of use must be evaluated separately in appropriate clinical studies. Patients should be enrolled into studies in the treatment of drug-susceptible or drug-resistant M. tuberculosis based on selection criteria intended to maximise the possibility that the results of susceptibility testing will confirm their eligibility. The population enrolled should be as representative as possible of the range of patients presenting with tuberculosis. Stratification according to important baseline factors is recommended (e.g. in terms of age, cavitation, extrapulmonary disease and HIV status).
In exploratory clinical investigations of efficacy the selection of regimens for further study may be based on biomarkers that are evaluated during or at the end of treatment. Nevertheless, none of these biomarkers has been shown to predict clinical outcomes at 24 months post-therapy. Confirmatory studies may assess the safety and efficacy of a test agent under conditions that include but are not limited to:
- Addition to or substitution for another agent within standard regimens to achieve shortened regimens, an improved safety profile, a lower potential for drug interactions or simplification of treatment for drug-susceptible M. tuberculosis
- Addition to optimised background treatment (OBT) regimens based on susceptibility test results to achieve superior efficacy to placebo + OBT in the treatment of drug-resistant M. tuberculosis.
The demonstration of a clinically important benefit for a test combination regimen in a primary analysis conducted at an appropriate time point may be considered sufficient to support an indication for use. Studies should plan to follow-up patients to 24 months post-therapy. An extrapolation of safety and efficacy in adults to some paediatric age groups may be justifiable, in which case it would be sufficient to establish appropriate age-specific dose regimens based on pharmacokinetic data obtained in children with tuberculosis. Nevertheless, children should also be followed for safety and efficacy using age-specific criteria for diagnosis and outcome assessments as appropriate.
The evaluation of the safety profile of a test agent for treating tuberculosis is confounded by the need to administer it as part of combination regimens in clinical studies. Identification of adverse reactions to the test agent should be possible when all other components of the regimens that are compared can be kept the same. However, this is not possible when the test agent has to be administered as part of a wide variety of combination regimens tailored to the susceptibility profiles of drug-resistant organisms
in individual patients. In all cases, a well-constructed and comprehensive Risk Management Plan is very important.
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.
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Interested party (Organisations or individuals) that commented on the draft Guideline as released for
consultation
Stakeholder
No.
Name of Organisation or individual
1 OARSI, Osteoarthritis Research Society International
2 USZ, Department of Rheumatology and Institute of Physical Medicine, University Hospital
of Zurich, Switzerland
3 AESGP, Association of the European Self-Medication Industry
4 EFPIA
5 GREES, Osteoarthritis section
6 EULAR
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 regulattions, rules and initiatives each month, and summarise 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.
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Since 2003 this guideline has presented guidance for the clinical development of slow-acting anti-rheumatic medicinal products aiming at symptom- and/or structure-modification (e.g. DMARDs, biologics) for the treatment of rheumatoid arthritis (RA). In the last years efforts have been made in that field with regard to the development of new products with an improved efficacy profile and novel insights have been gained with respect to the assessment of disease activity, joint damage and disability. Furthermore, new treatment strategies have been established which relate to early therapy, tight control and rapid switching of medication. Accordingly, new EULAR/ACR recommendations have been developed. Therefore several important additions and changes are needed to express the current state of scientific knowledge in this guideline.
The search for improved and meaningful endpoints and study designs adapted to the changed pharmacologic profile of new agents and elaborated treatment strategies has prompted several groups of scientists to develop new recommendations for conducting clinical studies in RA. A need is identified to update the regulatory guidance on the clinical development of medicinal products intended for the treatment of RA.
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.
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The MHRA are writing to consult you on whether to bring all nicotine containing products (NCPs) – with the exception of tobacco and tobacco products – within the medicines licensing regime, which would require all currently unlicensed NCPs on the market, such as electronic cigarettes containing nicotine and nicotine gels, to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a medicines marketing authorisation (MA).
This consultation should be read in conjunction with the draft Impact Assessment (IA). We would welcome views on whether to bring unlicensed NCPs within the medicines licensing regime. All replies will be considered before a final decision is made.
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.
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This consultation notifies interested parties that further amendments will be made to the Medicines For Human Use (Prescribing By EEA Practitioners) Regulations 2008
(2008 Regulations). This consultation seeks views on how current guidance can be expanded to provide additional support for community pharmacists following forthcoming legislative changes.
This consultation abides by the seven consultation criteria as set out in the revised Code of Practice on Consultation and which are summarised at Annex A. As the further
amendments to legislation are required for the purpose of complying with the views of the European Commission, a period of consultation of 4 weeks, although shorter than usually expected, is appropriate. Also, as those most affected by the further amendments to the 2008 Regulations will be members of the pharmacy profession, the consultation is being directed primarily to representatives of that profession, in addition to similar bodies representing medical, dental and other interests. However replies from other parties are welcome..
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.
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Organisations that commented on the document as released for consultation in June 2009 until September 2009.
1 Association of the European Self-Medication Industry (AESGP) Brussels, Belgium
2 Kooperation Phytopharmaka Bonn, Germany
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 regulattions, rules and initiatives each month, and summarise 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.
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Herbal medicinal products may contain significant levels of ethanol arising from its use as an extraction solvent in liquid extracts and tinctures or when added as a diluent to liquid herbal preparations. The use of ethanol is necessary for extraction of some constituents that are important for efficacy. Ethanol is metabolically active, therefore formulations without ethanol or with the lowest achievable level should be selected to avoid systemic exposure when the target population is children.
The scope of this paper is to reflect the need for safety limits for ethanol exposure by oral herbal medicinal products intended for the paediatric population. Establishing these limits is viewed as necessary to protect health and to allow safe free movement of goods within the EU. In addition, this will ensure a harmonised approach in assessment work among Member States as well as in the establishment by the HMPC of Community herbal monographs and of the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (respectively Article 16h (2,) and Article 16f (3) of Directive 2001/83/EC as amended).
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 regulattions, rules and initiatives each month, and summarise 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.
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Posted in Herbal, manufacturing
Tagged children, Ethanol, herbal medicinal products, herbal preparations, herbal substances, HMPC, paediatric use
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Organisations and/or individuals that commented on the draft Reflection Paper as released for
public consultation on 6 November 2008 until March 15th, 2009.
Organisations and/or individuals
1 Association of the European Self-Medication Industry (AESGP)
2 Kooperation Phytopharmaka, Germany
3 Association of Natural Medicine in Europe (ANME e.V.)
4 German Pharmaceutical Industry Association (BPI)
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 regulattions, rules and initiatives each month, and summarise 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.
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This guidance is intended to assist sponsors who are developing drug products with the potential for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b), 811(c)). Examples of products that are addressed in this guidance include new molecular entities and new dosage forms of drug substances already controlled under the Controlled Substances Act (21 U.S.C. 812(c)). Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change.2
Specifically, the guidance discusses the following:
• The definition of abuse potential
• Information on submitting an abuse potential assessment, including a proposal for scheduling
• A description of what constitutes an adequate abuse potential assessment
• Information for sponsors performing an assessment, including (1) the design and conduct of appropriate studies and investigations and (2) general administrative recommendations for submitting a proposal for scheduling
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 regulattions, rules and initiatives each month, and summarise 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.
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This guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U. S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances. This guidance recommends that an enhanced MC procedure (such as the one recommended in this guidance) can be used as an alternative to the current Apparatus Suitability procedure for Dissolution Apparatus 1 and 2 described in USP General Chapter <711> Dissolution. Regardless of whether the enhanced MC procedure or Apparatus Suitability procedure is used, the guidance also recommends that appropriate measures be taken to control the following sources of significant variability in dissolution testing: dissolved gases, vibration, and vessel dimensions.
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.
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Comments contributed by:
1 Industry Task Force and AIPES
2 EORTC
3 GE Healthcare LTD
4 International Society for Clinical Biostatistics (ISCB)
5 MSD
6 Novartis Pharma
7 Jorgen Hilden (Dept of Biostatistics, University of Copenhagen)
8 Anabel Cortes-Blanco
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 regulattions, rules and initiatives each month, and summarise 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.
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