Monthly Archives: September 2009

Biological Regulators Provide Guidance on Submission of Lot Release Protocols

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

FDA, CBER, Publish Guidance on Providing Regulatory Submissions in Electronic Format – Lot Release Protocols

The Center for Biologics Evaluation and Research (CBER), are issuing this guidance under 21 CFR 601.14(a) to assist you, manufacturers of biological products regulated by CBER, in submitting lot release protocols in electronic format to CBER’s Product Release Branch. This guidance supersedes the guidance of the same title dated July 2006. We are updating this guidance to delete references to 3.5 inch diskettes due to changes in technology that are phasing out the use of this type of electronic format.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Full Text Here

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Drug Regulators Publish Q4B Annex9 & 10

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FDA Publishes Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions – Annex 9: Tablet Friability General Chapter

This annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Full Text Here

FDA Publishes Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in ICH Regions – Annex 10: Polycrylamide Gel Electrophoresis General Chapter

This annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter.  The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

The ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the official pharmacopoeial texts, the section in Ph.Eur. 2.2.31.  Electrophoresis entitled “Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis (SDS PAGE)”, JP General Information 23. SDS-Polyacrylamide Gel Electrophoresis, and USP <1056> Biotechnology-derived Articles – Polyacrylamide Gel Electrophoresis, can be used as 120 interchangeable in the ICH regions.

Full Text Here

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Drug Regulators Publish Concept Paper on CJD in Plasma-Derived and Urine-Derived Medical Products

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

EMEA publishes a concept paper on the need for a position statement on CJD and Plasma-Derived and Urine-Derived Medical Products.

CONCEPT PAPER ON THE NEED TO UPDATE THE CHMP POSITION STATEMENT ON CJD AND PLASMA-DERIVED AND URINE-DERIVED MEDICINAL PRODUCTS
(EMEA/CPMP/BWP/2879/02 REV. 1)

The last revision of the “CHMP position statement on CJD and plasma-derived and urine-derived medicinal products” (EMEA/CHMP/BWP/2879/02/rev.1) was published in June 2004.
The document is the current EMEA/CHMP guidance on CJD and vCJD and plasma-derived and urine-derived medicinal products. It includes recommendations for these products based on the knowledge on CJD and vCJD epidemiology, human tissue distribution of infectivity/abnormal prion protein and infectivity in blood.

The current position statement dates from 2004. Additional information has been accrued in this field since 2004 including the finding of four cases of vCJD infection associated with blood transfusion of non-leucodepleted red blood cells.1,2 TSE infectivity has also been detected in urine in some animal models3,4,5,6 in the clinical phase of the disease.
The CHMP opinion and recommendations reflected in the position statement were based on the knowledge on CJD and vCJD at the time of publishing. The progress in the field during the subsequent years reinforces the need to update the content of the document and to review the recommendations for these products.
The current position statement covers plasma-derived medicinal products and urine-derived medicinal products. Currently, there is no specific guidance on CJD and vCJD and advanced therapy medicinal products based on human tissues.

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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US Senate Votes to Improve Drug Trial Access

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

Clinical Trial Access Improved by US Senate

just read an interesting article on www.Pharmaceutical-Technology.com

Four members of the US senate have introduced legislation to improve access to clinical trials for patients with rare diseases.

The “Improving Access to Clinical Trials Act” will allow patients with rare diseases to participate in clinical drug studies without losing their eligibility for public healthcare.

At present patients are prevented from accepting research compensation from clinical trials as it would make them ineligible to receive government medical benefits.

The move would also benefit researchers who often struggle to recruit patients with rare diseases such as cystic fibrosis due to limited patient populations and patient unwillingness to risk losing government support.

US Senator Ron Wyden said that for many suffering from rare diseases, access to clinical trials is their best hope for treatment.

“This legislation will make sure the small financial incentives these people receive will not be counted against them,” Wyden said.

The Improving Access to Clinical Trials Act is co-sponsored by Senators Ron Wyden (D-OR), Chris Dodd (D-CT), James Inhofe (R-OK) and Richard Shelby (R-AL).

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 Concept Paper on Clinical Investigation of Specific Immunoglobulins

Posted on September 29, 2009 by admin| Leave a comment

EMEA Publishes Concept Paper on The Need for Guidance on the Clinical Investigation of Specific Immunoglobulins

Full Paper Here.

Both guidelines on the core SmPC for human plasma-derived hepatitis B immunoglobulin, i.e. for intramuscular use (CPMP/BPWG/4222/02) and for intravenous use (CPMP/BPWG/4027/02), have been in operation since November 2006. Other specific guidelines on core SmPC, i.e. Core SmPC for human rabies immunoglobulin for intramuscular use (CPMP/BPWG/3728/02), Core SmPC for human tetanus immunoglobulin for intramuscular use (CPMP/BPWG/3730/02) and Core SPC for human varicella immunoglobulin for intramuscular use (CPMP/BPWG/3726/02) have been in operation since February 2006. Nevertheless, no guideline on the clinical investigation of these human specific immunoglobulins is currently available. As the regulatory experience from the marketing authorisation applications, especially for human plasma-derived hepatitis B immunoglobulin has been developing during the past decades, the development of a guideline appears appropriate.

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

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Drug Regulators Publish Guidance on Clinical Evaluation of Diagnostic Agents

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EMEA Publishes Guidance on the Clinical Evaluation of Diagnostic Agents

Full guidance here.

The revision of the points to consider on diagnostic agents was decided in order to reflect better the necessary steps in development of diagnostic agents as well as to define the assessment of benefits (technical performance, diagnostic performance, impact on diagnostic thinking and impact on patient management/outcome) and the risks related to the development of these agents. Principal chapters such as possible indications/claims, patient selection, endpoints, standard of truth, strategy and design of clinical trials, statistical considerations and data presentation, have also been reviewed. In addition, a chapter on the requirements for registration of products similar to already authorised products has
been added. The Appendix on the development of imaging agents has also been reviewed. Technical performance has been rewritten as well as the section on different types of blinding.
.

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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 Draft Guidance on Clinical Investigations for Factor IX Products

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EMEA Publishes Draft Guidance On the Clinical Investigations for Recombinant and Human Plasma Derived Factor IX Products

GUIDELINE ON THE CLINICAL INVESTIGATION OF RECOMBINANT AND HUMAN PLASMA-DERIVED FACTOR IX PRODUCTS

This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or plasma-derived factor IX products is made for use in treatment and prevention of bleeding in patients with haemophilia B. The guideline covers clinical investigations to be conducted pre- and post-marketing authorisation. The guideline is also provided for authorised products where a significant change in the manufacturing process has been made.

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 Draft Guidance on Clinical Investigations for Factor VIII Products

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EMEA Publishes Draft Guidance on Clinical Investigations of Recombinant and Human Plasma-Derived Factor VIII Products

GUIDELINE ON THE CLINICAL INVESTIGATION OF RECOMBINANT AND HUMAN PLASMA-DERIVED FACTOR VIII PRODUCTS

This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or plasma-derived factor VIII products is made for use in treatment and prevention of bleeding in patients with haemophilia A. The guidance covers clinical investigations to be conducted pre- and post-marketing authorisation. The guideline is also provided for authorised products where a significant change in the manufacturing process has been made.

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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Regulators Publish Q&A’s on EWP therapeutic subgroups on Pharmacokinetics

Posted on September 29, 2009 by admin| Leave a comment

The EMEA CHMP Efficacy Working Party Publish Q&A’s

Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on Pharmacokinetics.

In the context of assessment procedures, the Therapeutic Subgroup on Pharmacokinetics of the Efficacy Working Party (EWP-PK subgroup) is occasionally consulted by the CHMP or, following CHMP’s agreement, by other Committees, Working parties or the CMD(h). The objective is to address specific questions in relation to pharmacokinetic evaluations and particularly the requirements and assessment of bioequivalence studies. The positions, which are being elaborated by the EWP-PK subgroup in response to such questions, are being forwarded to the enquiring party for consideration in their assessment.
It is understood that such position will be reflected in the procedure-related assessment reports if applicable. In some cases however, these position might also be of more general interest as they interpret a very specific aspect that would not necessarily be covered by guidelines. This paper summarises these positions which have been identified as being within this scope. It should be noted that these positions are based on the current scientific knowledge as well as regulatory precedents. They should be read in conjunction with the applicable guidelines on bioequivalence in their current version. As the questions have initially been raised in the context of specific assessment procedures, details of these procedures have been redacted for reasons ofconfidentiality.
This compilation will be updated with new positions as soon as they become available. Likewise, if a  position is being considered outdated, e.g. due to new evolutions in the scientific knowledge including  revisions to the applicable guidelines, positions will be removed from this document.  The positions in this document are addressing very specific aspects. They should not be quoted as  product-specific advice on a particular matter as this may require reflection of specific data available  for this product. By no means should these positions be understood as being legally enforceable.

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Drug Regulators Publish Concept Paper Requiremtns for Guidance on the Clinical Investigation of Products for Lipid Disorders and Hypertension

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

EMEA Publishes Concept Paper on Guidance for Clinical Investigations for Lipid Disorders and Hypertension.

CONCEPT PAPER ON THE NEED TO UPDATE THE NOTE FOR GUIDANCE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE TREATMENT OF
LIPID DISORDERS (CPMP/EWP/3020/03) AND THE NOTE FOR GUIDANCE ON THE CLINICAL INVESTIGATION ON MEDICINAL PRODUCTS IN THE TREATMENT OF
HYPERTENSION (CPMP/EWP/238/95 REV. 2) TO DISCUSS THE NEED FOR OUTCOME STUDIES BASIS ON SAFETY DATA AT THE TIME OF MAA.

Current CHMP recommendations for the clinical development of lipid lowering and blood pressure (BP) lowering agents accept the possibility of drug registration for the so called biological indications. This means that the basis for the demonstration of the efficacy of these drugs can be their effect on biological markers (LDL-cholesterol and BP respectively). Not being the intention of the CHMP to modify this policy, more clarity is needed to explicitly state where these principles would not be applicable and further data on the effect of these medicinal products on morbidity and mortality would be requested before a marketing authorisation is given.

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Drug Regulators Publish Concept Paper on Paediatirc Pulmonary Arterial Hypertension

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

Drug Regulators EMEA Publish a Concept Paper on the Development of Paediatric Addendum on Clinical Investigations for the Treatment of Pulmonary Arterial Hypertension.

CONCEPT PAPER ON THE NEED FOR THE DEVELOPMENT OF A PAEDIATRIC ADDENDUM TO THE CHMP GUIDELINE ON THE CLINICAL INVESTIGATIONS OF MEDICINAL PRODUCTS FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION

The CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (PAH) addresses the regulatory aspects during the development of drugs for the treatment of PAH in adults. Five drugs are already registered through the centralized procedure for adult PAH, but no drug is specifically developed for this disease in the paediatric population. This concept paper discusses the need for regulatory guidance on the clinical development of drugs for PAH in the paediatric population.

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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 the Investigation of Medicincal Products in the Term and Preterm Neonate

Posted on September 28, 2009 by admin| 1 Comment

EMEA CHMP Publishes Guidance on the Investigation of Medicinal Products in the Term and Preterm Neonate.

Full Guidance Here

Neonates are the group of children from birth up to and including the age of 27 days, including term and preterm neonates. They represent a particularly vulnerable subgroup of the paediatric population. Whilst they account for a low percentage of the total use of medicines in childhood, up to 90 % of medicinal products are used unauthorised or off-label in this population, especially if treated on Neonatal Intensive Care Units (NICUs).
There are several reasons as to why few clinical trials of medicinal products have been performed in neonates (e.g. feasibility difficulties linked to: age, small patient group and uniqueness of their diseases.) The Regulation on Medicinal Products for Paediatric Use (Regulation (EC) 1901/2006) creates obligations with regards to conducting clinical trials in paediatric patients including neonates in order to meet the recognised need for authorised medicinal products and the information on the use of medicinal products in children. Therefore clinical trials to investigate medicinal products in the neonatal population have to address the needs of this population.
Neonatal studies encompass multiple difficulties, such as ethical (high vulnerability) and technical issues (immaturity, prematurity, lack of self assessment, need for specific formulations, high variability, etc). Notwithstanding the difficulties, the standards of the trials should remain the same.

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 Draft Guidance on E16 Genomic Biomarkers Related to Drug Response

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

FDA CBER Publish E16 Genomic Biomarkers Draft Guidance: Context, Structure and Format of Qualification Submissions

Full Guidance Here

The guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15. Biomarker qualification has not been covered in any ICH guideline. Qualification is a conclusion that the biomarker data submitted support use of the biomarker in drug discovery, development or post-approval and, where appropriate, in regulatory decision-making. The objective of the guideline is to create a harmonized structure for the qualification of genomic biomarkers that will foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities. It is also expected that the proposed document format will, where appropriate, facilitate incorporation of genomic biomarker data into specific product-related applications. Biomarker qualification can take place at any time during drug discovery, development or the post-approval period. For those instances where it is appropriate, general guidance for inclusion of biomarker qualification data into the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) format marketing authorization applications is provided in this document. The use of the CTD format would be expected when biomarker data are submitted as part of an NDA or MAA or upon request by the regulatory authorities.

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 Risk for Melamine Contamination

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

FDA publishes guidance on the risk of Melamine Contamination of Pharmaceutical Components.

Full Guidance Here

This guidance is intended to alert pharmaceutical manufacturers of finished products, pharmacy compounders, repackers, and suppliers to the potential risk of melamine contamination in pharmaceutical components. In September 2008, FDA received reports from China about food articles contaminated with melamine, which have resulted in thousands of hospitalizations for kidney problems and at least three deaths. As of the date of this guidance, FDA is not aware of any pharmaceuticals that have been contaminated with melamine. However, because of the potential risk of drug contamination, it is important that manufacturers take steps to ensure that susceptible components are not contaminated with melamine.
This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding better control their use of at-risk components3 that might be contaminated with melamine. FDA considers the presence of melamine in any drug (unless specifically approved as an impurity) to render that drug adulterated under sections 501(a)(2)(B) and 501(d) of the Act (21 U.S.C. 351(a)(2)(B) and 351(d)).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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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Twitter Weekly Updates for 2009-09-20

Posted on September 20, 2009 by admin| Leave a comment

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Drug Regulatos, FDA, Reppost Guidance on CMC Submissions for Therapeutic Recombinant DNA-Derived Products or Monolconal Antibody Products

Posted on September 14, 2009 by admin| Leave a comment

The FDA has re-posted guidance first published in 1996 “FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR A THERAPEUTIC RECOMBINANT DNA-DERIVED PRODUCT OR A MONOCLONAL ANTIBODY PRODUCT FOR IN VIVO USE”

This guidance provides a section by section description of the Chemistry, manufacturing and control section of an FDA submission, its aimed specifically at Specific Biotech products, but should be considered by other related technologies. There is no apparent reason for the re-posting but it could be the FDA is planning an update.

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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Twitter Weekly Updates for 2009-09-13

Posted on September 13, 2009 by admin| Leave a comment
  • News should be presented in the appropriate formatt! Headline, summary, detail. Its what the public want! #

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Drug Regulators Publish Concept Paper on CJD and Plasma-Derived Medicinal Products

Posted on September 8, 2009 by admin| Leave a comment

EMEA publishes Draft Guidance on Plasma and Urine Derived Medicinal Products and CJD

EMEA publishes “CONCEPT PAPER ON THE NEED TO UPDATE THE CHMP POSITION STATEMENT ON CJD AND PLASMA-DERIVED AND URINE-DERIVED MEDICINAL PRODUCTS
(EMEA/CPMP/BWP/2879/02 REV. 1)”

The proposed document will replace the CHMP Position statement on Creutzfeld-Jakob Disease and plasma-derived and Urine Derived Medical Products (EMEA/CPMP/BWP/2879/02 Rev 1)

These guidelines need to be updated because there have been 4 cases of vCJD infection associated with blood transfusion of non-leucodepleted red blood cells. TSE infectivity has also been detected in urine in some animal models.

In order to help the CHMP with developing this position statement they are seeking input from Industry and the Public.

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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UK Drug Regulators Release New Information on Medical Devices Directive

Posted on September 7, 2009 by admin| Leave a comment

UK Drug Regulators, MHRA, Release New Guidance for the Medical Device Directive: Information for Clinical Investigators

Full copy is available here.

In order to harmonise the process of getting approval for medical devices across Europe a common set of medical device regulations are being adopted, these are being guided by the medical devices directive. This all came into effect in 2002, and this is the latest guidance published on these guidelines.

In order to demonstrate and back up claims made for a medical device it is necessary to conduct clinical trials on Non-CE marked medical devices. In these circumstances a specifically designed clinical investigation is required. Before these trials can be conducted they need to be approved by the MHRA and an application should be filed 60 days before the trial is due to commence. An ethics committee approval is also needed for these trials, independent ethics committee opinions are not accepted by the MHRA.

These guidelines bring the medical devices process into line with the drugs guidelines in many respects. More detailed guidance on the conduct of clinical trials is also available. There is also updated guidance on vigilance systems.

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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Twitter Weekly Updates for 2009-09-06

Posted on September 6, 2009 by admin| Leave a comment
  • The Hudson bay start stop early and have a client facing review, it might just save your project from doom! #
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