Tag Archives: guidance

Health Canada releases draft guidance on classification of observations for inspection of cells, tissues and organs establishments

Posted on February 8, 2012 by damienbove| Leave a comment

Health Canada has released a draft guidance to assist with companies become compliant with the safety of human cells, tissues and organs for transplantation regulations which came into force on 7 December 2007. The purpose of this regulatory initiative is to minimise the potential health risks to Canadian recipient of human cells and tissues and organs. And to ensure that such organisations remain compliant with the proposed regulations.

More information is available on the Health Canada website

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FDA publishes guidance on the general principles for the development of vaccines for global infectious diseases

Posted on December 30, 2011 by damienbove| Leave a comment

The FDA is provided guidance to assist sponsors in developing vaccine to protect against global infectious diseases. The guidance focuses on development of licence of vaccines for infectious diseases or conditions endemic in areas outside the United States. It aims to clarify regulatory status and guidance already published for development of these products.

Full guidance given below

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EMA publish concept paper on updates to guidance on clinical development in HIV

Posted on December 19, 2011 by damienbove| Leave a comment

There are over 20 antiretroviral agents (ARTs) belonging to several classes that have been approved in the European Union. Recent approvals have seen improved tolerability and more convenient dosing regimens thus the therapeutic goal of most patients has changed in recent years as most are now aiming to suppress plasma viral load. However there are still a few patients that do not achieve sustained viral suppression either due to viral resistance or an inability to tolerate certain agents combinations. This changing landscape has pushed the MA towards changing guidance was adopted in 2008. New agents greatly enhance the likelihood that treatment experienced patients can achieve sustained viral suppression and thus the pool of failed patients has been constant dribbling reduced. However new anti-viral therapies are still needed. Existing guidance does not provide a feasible regulatory path the clinical development of such agents.

This concept paper looks at tackling this now complex drug development environment for HIV antiretroviral therapies.

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EMA published a concept paper on updating guidance for medical products to treat bacterial infections

Posted on December 7, 2011 by damienbove| Leave a comment

The EMA has published a concept paper inviting input from industry into a proposed update to the guidance on the evaluation medicinal products indicated for treat bacterial infections, to address indication specific clinical data requirements.

this initiative follows several requests were made to the CH MP to provide more detailed guidance on issues such as Pearson selection criteria and primary endpoints including efficacy variables and the timing of assessment outcomes. Specific interest was laid out non-inferiority study designs that would be acceptable to the regulators. A number of enquiries were concerned about the feasibility of achieving superiority endpoints in clinical studies and more guidance was needed to assist companies developing clinical programs that would be feasible and meet with regulatory approval in this area.

In response to this the EMA held a number of workshops and are now looking to make changes to the guidance to meet these issues.

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EMA Publush Guidance on the Treatment of Premenstrual Dysphotic Disorder (PMDD)

Posted on November 17, 2011 by admin| Leave a comment

EMA considers that there is sufficient research data available to support premenstrual dysphoric disorder (PMDD) at a diagnostic entity.

It is considered to have considerable public health impact in a small subpopulation of menstruating women. This guideline is to provide guidance on the clinical evaluation of products to treat this patient group.

excerpt from guidance

full text here

There are substantial research data available to support premenstrual dysphoric disorder (PMDD) as a diagnostic entity of a severe form of premenstrual disorder, which causes clinically relevant functional impairment and requires treatment. It is considered a disorder with substantial clinical and public health impact in a [small] subpopulation of menstruating women. The aim of this guideline is to provide guidance for the evaluation of medicinal products in the treatment of PMDD.
The present document should be conceived as general guidance, and should be read in conjunction with other applicable EU and ICH guidelines (see Section 3)..

Up to 70-90 % of women of reproductive age have one or more signs of physical discomfort or emotional symptoms in the premenstrual, i.e. luteal phase of their menstrual cycle. About 20-40 % of menstruating women have premenstrual syndrome (PMS) and experience luteal phase symptoms that are bothersome. A smaller number, up to 8 %, experience more severe symptoms, which lead to substantial distress or functional impairment and are referred to as premenstrual dysphoric disorder (PMDD) (10, 11, 13, 14, 23, 38, 39, 42). Although PMDD, like PMS includes physical symptoms, it always involves a worsening of mood that interferes significantly with the woman’s quality of life. The burden of illness of PMDD results from the severity of luteal phase symptoms, the chronicity of the disorder and the impairment in work, relationships and activities.
In the last decades a very broad diagnostic concept of the premenstrual disorders PMS and PMDD has been used in clinical research, which produced different diagnostic criteria and highly heterogeneous study populations.
Recent advances and research data improved the knowledge on diagnosis, frequency, pathophysiologic mechanisms, and treatment options in PMDD. This led to treatment recommendations by learned societies for PMDD.

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EMA Publish Concept Paper on Addendum to Guidance on Evaluation of Treatments for Bacterial Infections

Posted on October 18, 2011 by admin| Leave a comment

EMA Publish Concept Paper on Addendum to Guidance on Evaluation of Treatments for Bacterial Infections

This Concept Paper proposes the development of an addendum to the Note for Guidance on Evaluation of New Anti-bacterial Medicinal Products (CPMP/EWP/558/95 Rev 2).
During the revision of the previous version of the guideline (CPMP/EWP/558/95 Rev 1) consideration was given to the need to develop guidance on clinical data requirements to support the approval of specific indications for use. During the consultation period several requests were made for the CHMP to provide more detailed guidance on issues such as patient selection criteria and primary endpoints, including efficacy variables and the timing of the assessment of outcomes. It was proposed that CHMP should give further consideration to, and provide additional clarification regarding, indications for which superiority or non-inferiority study designs could be accepted. In the case of superiority studies, it was requested that further consideration should be given to the feasibility of conducting comparisons between test agents and either placebo or active comparators. In the case of non-inferiority studies there were requests for further consideration of appropriate values of delta. More guidance was considered to be needed regarding clinical development programmes for new antibacterial agents with potential for clinical activity against rare and/or multidrug-resistant pathogens and the accumulation of data to support indications for which there is currently no established regulatory pathway.

In order to gain further insight into the issues raised during consultation a 2-day Workshop was held in February 2011 at which representatives from the pharmaceutical industry and academia met with EU  Regulators to discuss several of these matters (insert link to final published report). Taking into account the written comments received during the consultation period and the discussions during this Workshop it appeared to be appropriate to provide additional guidance along the lines requested. It is proposed that following adoption of the revision of the main guidance document an addendum should be developed to provide indication-specific guidance. The issues that have been identified for inclusionor further consideration in the addendum are detailed below.

The content of CPMP/EWP/558/95 Rev 2 covers the general approach to the development of antibacterial agents. This guideline (as with its predecessors) does not provide detailed indicationspecific guidance. It is now apparent that such guidance is needed in order to describe and clarify the CHMP’s position on various matters.



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EMA Publish Guidance on Non-Clinical and Clinical Development for HIV Prevention

Posted on June 21, 2011 by admin| Leave a comment

EMA Publish Guidance on Non-Clinical and Clinical Development for HIV Prevention

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Besides the ongoing efforts to develop preventive vaccines, other HIV prevention methods are currently also under development: oral and topical Pre-Exposure Prophylaxis (PrEP) for HIV sexual transmission.
After decades of research in these fields, the positive results of two recent studies have called the attention of the scientific community and regulators.
1- tenofovir 1% vaginal gel has been shown to reduce the risk of HIV acquisition by 39% (incidence rate ratio versus placebo = 0.61 (CI: 0.4 to 0.94; p=0.017) in the double blind placebo-controlled CAPRISA study performed in 889 women in South Africa.
2- the oral fixed dose combination Truvada (tenofovir and emtricitabine) has been shown to reduce the HIV incidence as compared to placebo by 44% (CI: 15 to 63; p=0.005) in the iPrEx study performed in 2499 men who have sex with men (MSM).
These approaches are developed as potential “complementary” tools to the standard prevention that still mainly relies on condom use.
This concept paper addresses the need for a reflection paper on the key aspects to be covered by the non clinical and clinical developments of oral and topical PrEP in view of potential future applications for marketing authorisation, including applications for a scientific opinion under article 58 for countries outside the EU.
Although it is acknowledged that different populations at risk could be targeted by oral and topical (genital and rectal) PrEP in different epidemiological contexts (from low level to generalised HIV epidemics) with varying HIV prevalences, both oral and topical PrEP approaches are being addressed in parallel in this document as they will raise similar issues.

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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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EMA Publish Concept Paper on HIV Prevention Medical Products

Posted on March 10, 2011 by admin| Leave a comment

EMA Publish Concept Paper on HIV Prevention Medical Products

Besides the ongoing efforts to develop preventive vaccines, other HIV prevention methods are currently also under development: oral and topical Pre-Exposure Prophylaxis (PrEP) for HIV sexual transmission.
After decades of research in these fields, the positive results of two recent studies have called the attention of the scientific community and regulators.
1- tenofovir 1% vaginal gel has been shown to reduce the risk of HIV acquisition by 39% (incidence rate ratio versus placebo = 0.61 (CI: 0.4 to 0.94; p=0.017) in the double blind placebo-controlled CAPRISA study performed in 889 women in South Africa.
2- the oral fixed dose combination Truvada (tenofovir and emtricitabine) has been shown to reduce the HIV incidence as compared to placebo by 44% (CI: 15 to 63; p=0.005) in the iPrEx study performed in 2499 men who have sex with men (MSM).
These approaches are developed as potential “complementary” tools to the standard prevention that still mainly relies on condom use.
This concept paper addresses the need for a reflection paper on the key aspects to be covered by the non clinical and clinical developments of oral and topical PrEP in view of potential future applications for marketing authorisation, including applications for a scientific opinion under article 58 for countries outside the EU.
Although it is acknowledged that different populations at risk could be targeted by oral and topical (genital and rectal) PrEP in different epidemiological contexts (from low level to generalised HIV epidemics) with varying HIV prevalences, both oral and topical PrEP approaches are being addressed in parallel in this document as they will raise similar issues.

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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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NICE, The UK HMO, Publishes Guidance on Percutaneous Mitral Valve Annuloplasty.

Posted on August 19, 2010 by admin| Leave a comment

NICE, The UK HMO, Publishes Guidance on Percutaneous Mitral Valve Annuloplasty.

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Current evidence on the safety and efficacy of percutaneous mitral valve annuloplasty is inadequate in quality and quantity. Therefore this procedure should only be used in the context of research, which should clearly describe patient selection, concomitant medical therapies and safety outcomes. Both objective measurements and clinical outcomes should be reported.

Percutaneous mitral valve annuloplasty should only be carried out by interventional cardiologists with specific training in the procedure.

NICE may review the procedure on publication of further evidence.

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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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Drug Regulator, EMA (EMEA), Publish Concept Paper on Need for A Guideline on the Clinical Development of Thrombopoetin Receptor Agonists for the Treatment of Chronic Immune (idiopathic) Thrombocytopenic Purpura

Posted on June 9, 2010 by admin| Leave a comment

Drug Regulator, EMA (EMEA), Publish Concept Paper on Need for  A Guideline on the Clinical Development of Thrombopoetin Receptor Agonists for the Treatment of Chronic Immune (idiopathic) Thrombocytopenic Purpura.

FullText Here

Thrombopoetin agonists constitute an innovative approach for the management of patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP). Over the recent past, a number of requests for Scientific Advice and Marketing Authorisation Applications have been assessed by the CHMP, thus giving sufficient basis issuing recommendations on the clinical development of this type of drugs in ITP patients.

A number of Marketing Authorisation Applications of medicinal products for the treatment of ITP have been evaluated in the recent past by the CHMP. These drugs, being of substantially different origin and structure, share the same mechanism of action, namely the stimulation of thrombopoetin receptors. This is a completely innovative approach in the treatment of ITP, which is deemed a relevant added tool for the management of these patients. A number of important aspects dealing with the evaluation
of both the safety and efficacy of this new type of drugs have triggered the need for specific CHMP guidance relating to the clinical investigation of these products in ITP.

Considering the new therapeutic alternatives to deal with the thrombocytopenia based on the stimulation of production of platelets by megakaryocytes in the marrow, different molecules have been developed (a recombinant polypeptide and a low molecular weight, synthetic, non-peptide molecule are available which act as agonists of thrombopoetin receptor). Up to now, no formal EU guidelines on the clinical development of products for ITP were available, and the regulatory experience was limited
to classical immunoglobulin therapy for which, considering the wide clinical experience, only limited clinical data had been requested. Thrombopoetin receptor agonists constitute an innovative therapeutic approach which certainly is felt to fill an unmet medical need in chronic refractory ITP patient population. This approach has lead however to carefully reconsider which type of clinical data, in terms of both safety and efficacy, should be requested to allow a proper benefit/risk evaluation. Key relevant aspects would be the dose selection, the definition of the therapeutic goal, identification of relevant target populations and discussion particular safety aspects linked to the mechanism of action of these drugs and /or their molecular structure. Importantly, children deserve specific reflections, since disease features may be different with respect to adults.

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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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ida consultants freestrategyconsultation 515x64 Drug Regulator, EMA (EMEA), Publish Concept Paper on Need for A Guideline on the Clinical Development of Thrombopoetin Receptor Agonists for the Treatment of Chronic Immune (idiopathic) Thrombocytopenic Purpura

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Drug Regulators, EMA, Publish Concept Paper on the Need for Revision of the Guideline on the Clinical Development of Medicinal Products for the Treatment of Hepatitis C

Posted on May 15, 2010 by admin| Leave a comment

Drug Regulators, EMA, Publish Concept Paper on the Need for Revision of the Guideline on the Clinical Development of Medicinal Products for the Treatment of Hepatitis C.

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Hepatitis C virus (HCV) is a leading cause of chronic liver disease, cirrhosis, and hepatocellular carcinoma, as well as the most common indication for liver transplantation in many European countries. Worldwide, the number of chronically infected persons is estimated at 170 million, or 3% of the global population. About 20-30% of chronically infected persons will advance to cirrhosis within 20 years. In Europe around 1/3 of HIV-infected patients are co-infected with HCV, with a prevalence of 50% in some regions in southern Europe. Compared to HCV mono-infected patients, these patients have faster progression of liver fibrosis; the risk for manifest cirrhosis is doubled for a middle-aged man carrying both infections. The present standard of care (SOC) treatment for hepatitis C is a combination of ribavirin and pegylated interferon (PEG-IFN) alpha 2a or 2b. Whereas PEG-IFN is an immunomodulator, the mechanism of action of ribavirin is not precisely understood. The field of hepatitis C therapy, however,
is presently one of intense investigational activity, with numerous directly acting antiviral (DAA) compounds with different mechanisms of action presently undergoing phase I-III trials. The first marketing applications for such agents are foreseen in 2010.

The first CHMP guidelines on the “Clinical Evaluation of Direct Acting Antiviral Agents Intended for Treatment of Chronic Hepatitis C” (CHMP/EWP/30039/08) were published in May 2009. Due to the limited experience with other approaches to the clinical development of DAAs, this guideline primarily addresses studies in which new DAAs are added to SOC treatment for chronic hepatitis C (CHC). The discussion of other therapeutic approaches, such as the combination of DAAs with or without SOC
components, is rather rudimentary, as is the issue of labelling requirements in special populations. Indeed, in the extant guideline it is recognised that “due to the dynamics of the field and the restricted scope of this guideline, revisions and amendments are foreseen to be necessary within a short frame of time”. Particular issues for new or updated guidance would include:
• Study design, dose selection and populations when evaluating DAA combinations without SOC or PEG-IFN.
• Study design and endpoints in patients with decompensated liver disease.
• Studies pre- and post transplant.
• Requirements for licensure in genotypes with a low prevalence in the developed world.
• Updated guidance on DAA resistance.
• Study design and populations for confirmatory trials in HCV/HIV co-infected patients.
• Benchmark pharmacodynamics, viral load and resistance assays.
• The use of non-invasive methods for liver assessment.
• The study of DAAs in DAA-experienced patients.
• The use of genetic predictors of SOC activity for DAA study design.
• Studies in children.

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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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ida consultants freestrategyconsultation 515x64 Drug Regulators, EMA, Publish Concept Paper on the Need for Revision of the Guideline on the Clinical Development of Medicinal Products for the Treatment of Hepatitis C

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Drug Regulators, EMA (EMEA),Publish Guidance on the Development of Medicinal Products for the Treatment of Alcohol Dependence

Posted on March 8, 2010 by admin| Leave a comment

Drug Regulators, EMA (EMEA),Publish Guidance on the Development of Medicinal Products for the Treatment of Alcohol Dependence

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Alcohol dependence is in general accepted as a psychiatric disorder with harmful physical, mental and social consequences and a high probability of a chronic relapsing course. It is considered a major public health problem in most Western societies. The aim of this guideline is to provide guidance on clinical studies for drugs developed for the treatment of alcohol dependence. The present document should be conceived as general guidance, and should be read in conjunction with other applicable EU and ICH guidelines.

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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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Drug Regulators, EMEA (EMA), Publish Comments Draft Guidance on the Investigation of Bioequivalence

Posted on March 1, 2010 by admin| Leave a comment

Drug Regulators, EMEA (EMA), Publish Draft Guidance on the Investigation of Bioequivalence.

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Organisations that commented on the draft Guideline as released for consultation

1 EFPIA
2 European Generic medicines Association (EGA)
3 EUFEPS Network on BABP
4 FIP Special Interest Group on BCS and Biowaiver
5 BPI-German Pharmaceutical Industry Association
6 The Association of the European Self Medication Industry (AESGP)
7 European Federation of Statisticians in the Pharmaceutical Industry
8 European Quality Assurance Confederation
9 International Association for Pharmaceutical Technology
10 BEBAC-Consultancy Services for bioequivalence and Bioavailability Studies
11 CIPLA LTD. INDIA
12 Pharmascience Inc. Montreal, Canada
13 Anapharm
14 Lupin Bioresearch Center
15 MANEESH PHARMACEUTICALS, LTD
16 MDS PHARMA SERVICES
17 POLFA TARCHOMIN S.A
18 PHAST GmbH
19 Jenson Pharmaceutical Services Ltd
20 Douglas Pharmaceuticals Ltd
21 Ratiopharm GmbH
22 Ranbaxy
23 Orion Corp. Orion Pharma
24 Gilead Sciences International Ltd
25 CEPHA s.r.o.
26 H.L. Lundbeck A/S
27 Combino-pharm
28 Bayer Schering Pharma AG/Clinical Pharmacology and Global Pharmacometrics
29 Quinta Analytica-s.r.o.
30 Hexal AG
31 Synthon BV
32 UCB Pharma S.A.
33 Merck Sharp & Dohme (Europe) Inc
34 ACC GmbH, Analytical Clinical Concepts

35 Slovak National Accreditation Service
36 Good Laboratory Practice Monitoring Authority
37 Norwegian Accreditation
38 Eye- Care Industries European Economic interest grouping
39 Dr. Nasir Idkaidek
40 Patrick Nicolas
41 Atholl Johnston
42 Laszlo Endrenyi
43 Aldo Rescigno
44 Carla M Catsmella
45 Salvador Fudio
46 Dr. Kamal K. Midha and Dr. Gordon McKay
47 Swissmedic

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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ida consultants freestrategyconsultation 515x64 Drug Regulators, EMEA (EMA), Publish Comments Draft Guidance on the Investigation of Bioequivalence

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Drug Regulators, MHRA, Publish Best Practice Guidance on the Same of Pain Relief

Posted on March 1, 2010 by admin| Leave a comment

Drug Regulators, MHRA, Publish Best Practice Guidance Poster on the Same of Pain Relief.

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Medicines for pain relief on general sale are effective and acceptably safe when used according to the label instructions. But there is evidence to show that people sometimes use large quantities of these medicines impulsively. Restricting the availability of pain relief medicines for purchase and in the home is effective in reducing the number of hospital admissions and deaths from accidental or impulsive overdose.

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FDA Publishes Draft Guidance on E7 Studies in Support of Special Populations: Geriatrics Q&A

Posted on December 16, 2009 by admin| Leave a comment

FDA Publishes Draft Guidance on E7 Studies in Support of Special Populations: Geriatrics Q&A

FDA Publishes Draft Guidance on E7 Studies in Support of Special Populations: Geriatrics Q&A full text available here

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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ida consultants freestrategyconsultation 515x64 FDA Publishes Draft Guidance on E7 Studies in Support of Special Populations: Geriatrics Q&A

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Drug Regulators, EMEA, Publish Guidance on the Development of therapies for Cystic Fibrosis

Posted on November 30, 2009 by admin| Leave a comment

Drug Regulators, EMEA, Publish Guidance on the Development of therapies for Cystic Fibrosis

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CF is a life threatening and chronically debilitating disease, impairing the Quality of life, characterised by progressive bronchiectasis and obstructive pulmonary disease (> 90% patients). The lower respiratory tract involvement is the primary cause of morbidity and mortality in patients with CF (> 90% of fatalities). Ninety percent of CF patients are colonised with Pseudomonas aeruginosa (PA), and PA infections are the cause of mortality in 80% of those patients.

CF is mainly a paediatric disease. Life expectancy is considerably shortened due to respiratory damage-induced morbidity and mortality. However, due to the advances of past 20 years in the prophylaxis of chronic respiratory infection, along with the systematic supplement of pancreatic enzyme and decrease in malnutrition CF patients reach a mean 30 to 40 years of age, and the proportion of adult CF patients increases.

The guidance will focus on:
• clinical trials design in lung involvement and clinically relevant endpoints (mucociliary clearance and broncho-pulmonary infections (mortality), in particular: treatment of PA early colonisation, chronic infection and exacerbations; prophylaxis of chronic PA infection; slowing/stopping lung damages (fibrosis, bronchiectases)
• clinical trials design in pancreatic involvement, in particular management of exocrine pancreatic insufficiency and malnutrition.

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Drug Regulators Publish Guidance for Allogenic Pancreatic Islet Cell Products

Posted on October 30, 2009 by admin| Leave a comment

Drug Regulators,FDA, Publish Guidance for Allogenic Pancreatic Islet Cell Products

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This guidance provides recommendations to manufacturers, sponsors, and clinical investigators involved in the clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus. The FDA, are issuing this guidance to assist with identifying data and information obtained during investigational new drug (IND) studies that might be helpful in establishing the safety, purity, and potency of a biological product. This guidance is not intended to identify all of the product, preclinical, and clinical data that might be needed to successfully support a biologics license application (BLA). This guidance finalizes the draft guidance of the same title, dated May 2008.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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Drug Regulators Publish Guidance on End-of-Phase 2a Meetings

Posted on October 28, 2009 by admin| Leave a comment

Drug Regulators, FDA CDER, Publish Guidance on End-of-Phase 2a Meetings

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This guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The purpose of an EOP2A meeting is to facilitate interaction between FDA and sponsors who seek guidance related to clinical trial design employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, placebo group responses, disease), designing trials for better dose response estimation and dose selection, and other related issues. This guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors.
An EOP2A meeting would occur after the completion of clinical trials that provide data on the relationship of dosing and response for the particular intended use (including trials on the impact of dose ranging on safety, biomarkers, and proof of concept). For the purposes of this guidance, end of phase 2A occurs after the completion of phase 1 trials and the first set of exposure-response trials in patients, and before beginning phase 2B (i.e., patient dose-ranging trial) and phase 3 clinical efficacy-safety trials. In the context of drug development programs, discussions at an EOP2A meeting could include exploration of dose estimation and dose selection to use in late stage efficacy trials. Where novel trial designs are a possibility, their utility and applicability could be discussed at an EOP2A meeting.
This guidance focuses on the following specific topics:
● Objectives of the EOP2A meeting
● Considerations for evaluating EOP2A meeting requests
● Useful information for an EOP2A meeting package
● EOP2A meeting arrangements

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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 guideline ap
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Drug Regulator Publishes Core SPC for Pandemic Influenza Vaccines

Posted on October 22, 2009 by admin| Leave a comment

Drug EMEA Regulator Publishes Core SPC for Pandemic Influenza Vaccines

Two guidelines have been developed by the Vaccine Working Party (VWP) on Pandemic
Influenza vaccines:
- Guideline on dossier structure and content for marketing authorisations for pandemic
influenza vaccines (EMEA/CPMP/VEG/4717/03 Rev-1);
- Guideline on submission of marketing authorisation applications for pandemic
influenza vaccines through the centralised procedure (EMEA/CPMP/VEG/4986/03).
This harmonised SPC has been developed by the VWP in order to facilitate the submission of
the core pandemic dossier and subsequent approval of the pandemic variation: the SPC, based
upon this harmonised SPC proposal, labels and package leaflet approved in the core pandemic
dossier authorisation will normally not have to change (except for some information on the
pandemic strain) when the pandemic variation is submitted. It is intended solely for
inactivated pandemic virus derived vaccines. Please note that the text proposal should be
considered as a minimum requirement. Additional claims should be substantiated with data.
It should be read in conjunction with the following additional guidance documents:
- Guideline on Summary of Product Characteristics, published by the European
Commission
- Guideline on Pharmaceutical aspects of the product information for human vaccines
(EMEA/CPMP/BWP/2758/02)
- QRD Product Information Template with explanatory notes
- Convention to be followed for QRD Templates

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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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Drug Regulators Publishes Guidance on Managing Donor Risk for HIV-1

Posted on October 12, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Recommendations for Management of Donor at Increased Risk of HIV-1 infection.

The Food and Drug Administration (FDA), are providing the, blood and plasma establishments, with a revised list of countries that should be included in questions for identifying donors at increased risk for HIV-1 group O infection. They are also providing recommendations for discontinuing the use of some questions used to identify these donors and for management of donors previously deferred. This guidance supersedes the memorandum entitled “Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection,” dated December 11, 1996 (Ref. 1). That memorandum contained interim measures to reduce the risk of HIV-1 group O transmission by blood and blood products pending licensure of test kits specifically labeled for detection of antibodies to HIV-1 group O viruses. Now that an FDA-licensed test for detection of antibodies to HIV-1 group O viruses is available, those interim recommendations are no longer current.

Full Recomendation Here.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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 guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators Publishes Guidance on Managing Donor Risk for HIV 1

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