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Design and Analysis of Virus Shedding Studies for gold 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) Issuing this guidance is to Provide you, sponsors of bacteria or virus-based gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic products)2 with recommendations how to conduite is shedding During preclinical studies and clinical development.


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

This Regulation Establishes lays down rulesconcernant the Placing on the market, making available put on the market orthings Into Service of medical devices and accessories to medical devices for human use in the Union.This regulation aussi Applies to clinical investigations Conducted medical devices are in the Union.


Botanical Drug Development Draft Guidance for Industry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 information on the general 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 apply to May aussi thesis products.


Annual report of the Pharmacovigilance Inspectors Working Group for 2014

Ce document est the seventh annual report of the Pharmacovigilance Inspectors Working Group. The IWG PhV1 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 IWG PhV Mandate Was endorsed by the Heads of Medicines Agencies is 18-19 May 2009 and by the Agency's Management Board on October 1 2009, thereby Formally Establishing the PhV IWG.


Analytical Procedures and Methods Validation for Drugs and Biologics

This guidance supersedes the draft of the Sami Name That published on February 19, 2014 (EN 79 16 9467) and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods Validationand the 1987 Guidelines for Submitting Samples and Analytical Data for MethodsValidation. It provides recommendations on how you, the application covered, can submit analytical procedures4 and validation methods5 data carrier to the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.


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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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