Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products - Guidance for Industry

The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene Therapies (OCTGT) is issuing this guidance to provide you, sponsors of virus or bacteria-based gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic products)2 with recommendations on how to conduct shedding studies during preclinical and clinical development.  

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Proposal for a Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

This Regulation establishes lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices and accessories to medical devices for human use in the Union. This regulation also applies to clinical investigations on medical devices conducted in the Union. 

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Botanical Drug Development Draft Guidance for Industry

This guidance describes the Center for Drug Evaluation and Research’s (CDER’s) current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. 

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Annual report of the Pharmacovigilance Inspectors Working Group for 2014

This document is the seventh annual report of the Pharmacovigilance Inspectors Working Group. The PhV IWG1 has been established by the European Medicines Agency (hereinafter “the Agency”) within the scope of Article 57(1)(i) of Regulation (EC) No 726/2004. Following a report on the first year of operation the PhV IWG mandate was endorsed by the Heads of Medicines Agencies on 18-19 May 2009 and by the Agency’s Management Board on 1 October 2009, thereby formally establishing the PhV IWG.

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Analytical Procedures and Methods Validation for Drugs and Biologics

This guidance supersedes the draft of the same name that published on February 19, 2014 (79 FR 16 9467) and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and the 1987 Guidelines for Submitting Samples and Analytical Data for MethodsValidation. It provides recommendations on how you, the applicant, can submit analytical procedures4 and methods validation5 data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

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