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"This draft guidance describes the suggested contents for the pharmaceutical development section in the quality module of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The draft guidance is intended to assist in the development of pharmaceutical studies that provide scientific understanding to support the establishment of specifications and manufacturing controls and serve as the basis for evaluating risk management over the life cycle of the product."

http://www.fda.gov/cber/gdlns/ichq8pharm.pdf
http://www.fda.gov/cder/guidance/6672dft.pdf

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The FDA announced in a Federal Register notice of October 4, 2004, the availability of a guidance for industry entitled “Sterile Drug Products Produced by Aseptic Processing -Current Good Manufacturing Practice.' This guidance explains FDA's current thinking on manufacturing of sterile drug products produced by aseptic processing in the context of complying with certain sections of the current good manufacturing practice (CGMP) regulations for drug and biological products. This guidance is issued with the goal of providing clear and consistent communication of regulatory expectations to promote voluntary compliance with current FDA requirements.

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Further Information:
The FDA announced in a Federal Register notice of October 4, 2004, the availability of a draft guidance for industry entitled “Current Good Manufacturing Practices for Combination Products.” Once finalized, this guidance will provide guidance to industry and FDA staff on the applicability of current good manufacturing practices (CGMP) for combination products.

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"The FDA's Centre for Biologics Evaluation and Research (CBER), USA posted (8 November 2004) notice of the publication of the Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)."

Part 1: Conducting Safety Assessments
Part 2: Clinical Indications
Part 3: Design, Analysis, and Interpretation of Clinical Studies

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Further Information:
The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), USA posted (6 September 2002) notice of Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals. This draft guidance document has been released for comment from interested parties.

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Posted on CBER website on January 9th 2002, dated January 2002. This guidance document contains comprehensive revised recommendations, to all registered blood and plasma establishments for deferral of donors with possible exposure to the agent of vCJD, based upon advisory committee discussions, internal Public Health Service and FDA deliberations, and public comments. FDA has developed recommendations for donor deferral, and product retrieval, quarantine, and disposition based upon consideration of risk in the donor and product, and the effect that withdrawals and deferrals might have on the supply of life- and health-sustaining blood components and plasma derivatives. The new recommendations are intended to minimize the possible risk of CJD and vCJD transmission from blood and blood products while maintaining their availability.
The guidance document finalizes the draft guidance of the same title, dated August 2001, and supersedes the guidance document entitled "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products" dated November 1999.

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CBER posted (11 July 2002) the Gene Therapy Patient Tracking System (GTPTS). The GTPTS is intended to supplement or replace current systems for assessing and promoting the safety of gene therapy so that the oversight system will be optimized for dealing with relatively specific gene therapy issues. CBER has identified five areas in which the GTPTS can improve upon pre-existing FDA (Food and Drug Administration) systems for assessing and promoting product safety.

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Posted: 2/1/2002 Issued: 2/1/2002 The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their Intimate Contacts" dated February 2002. The draft guidance document provides recommendations to all registered blood and plasma establishments, and establishments engaged in manufacturing plasma derivatives. The draft guidance document, when finalized, is intended to provide recommendations regarding the disposition of blood products manufactured from a donor who is retrospectively discovered to have received a xenotransplantation product or to have been an intimate contact of a xenotransplantation product recipient. This is the second draft guidance document and it incorporates revisions based on public comments received on the first draft guidance document by the same name announced in the Federal Register of December 30, 1999 (64 FR 73562).

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Further Information:
Posted on CBER website on January 9th 2002, dated January 2002. This guidance document contains comprehensive revised recommendations, to all registered blood and plasma establishments for deferral of donors with possible exposure to the agent of vCJD, based upon advisory committee discussions, internal Public Health Service and FDA deliberations, and public comments. FDA has developed recommendations for donor deferral, and product retrieval, quarantine, and disposition based upon consideration of risk in the donor and product, and the effect that withdrawals and deferrals might have on the supply of life- and health-sustaining blood components and plasma derivatives. The new recommendations are intended to minimize the possible risk of CJD and vCJD transmission from blood and blood products while maintaining their availability.
The guidance document finalizes the draft guidance of the same title, dated August 2001, and supersedes the guidance document entitled "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products" dated November 1999.

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