Performance & Innovation !
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COMPETITIVE AND BUSINESS INTELLIGENCE
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US FDA DRAFT GUIDANCE |
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Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing Individual Case Safety Reports
This guidance on ICSRs supersedes the Expedited Reports draft guidance in its entirety and the ICSR and ICSR attachment portion of the Periodic Reports draft guidance. The descriptive information portion of the Periodic Reports draft guidance is now addressed only in other Agency guidance. Full Document...
Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)
Due to the availability of a licensed HBV NAT and the improved specificity of anti-HBc assays, we are proposing a reentry algorithm for anti-HBc in this guidance. Full document...
Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
This guidance is intended to provide recommendations to you, manufacturers, sponsors, and clinical investigators involved in the clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus. Full document...
Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for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...
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This draft guidance document represents the Food and Drug Administration's current thinking on this topic.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...
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...
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...
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