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COMPETITIVE AND BUSINESS INTELLIGENCE

US FDA DRAFT GUIDANCE


Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

The potential for WNV transmission by blood transfusion during the acute phase of infection, when infected individuals are viremic and asymptomatic, was first recognized in 2002 (Ref. 2). At that time, test kit manufacturers and blood organizations, with input from the Public Health Service (National Institutes of Health, FDA, and Centers for Disease Control and Prevention CDC)) Full document...

01 May 2008, Intelligent Agent
Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 -

This draft guidance document represents the Food and Drug Administration's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Full document...

21 Apr 2008, Intelligent Agent
ICH Draft Guidance: S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

The primary focus of this guidance is testing of "small molecule" drug substances, and not biologics as defined in the ICH S6 guidance. Full document...

26 Mar 2008, Intelligent Agent
Questions and Answers on the Draft Guidances

The Food and Drug Administration (FDA) is issuing for public comment two draft guidances regarding L. monocytogenes in ready-to-eat (RTE) foods. Full document...

13 Mar 2008, Intelligent Agent
Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products

This guidance applies to somatic cellular therapy and gene therapy products. This guidance does not apply directly to human cells, tissues, and cellular and tissue products (HCT/Ps) which are regulated solely under Section 361 of the Public Health Service Act as described under 21 CFR 1271.10, or HCT/Ps which are regulated as medical devices under 21 CFR Part 820. Full document...

12 Feb 2008, Intelligent Agent
ICH: Draft Guidance: Q8(R1) Pharmaceutical Development - Revision 1

This guidance is an annex to ICH Q8 Pharmaceutical Development and provides further clarification of key concepts outlined in the core guideline. In addition, this annex describes the principles of quality by design (QbD). Full document...

11 Jan 2008, Intelligent Agent

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