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US FDA DRAFT GUIDANCE |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Draft Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products
We, FDA, are issuing this guidance to provide you, manufacturers of plasma-derived products, with recommendations for performing parvovirus B19 nucleic acid testing (NAT) as an in-process test for Source Plasma and recovered plasma used in the further manufacturing of plasma-derived products. Full document...
Guidance for Industry: E2F Development Safety Update Report
The main focus of the DSUR is data from interventional clinical trials (referred to in this document as “clinical trials”) of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors. Full document...
Guidance for Industry: International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions;
- Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter. Full document...
- Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter. Full document...
- Annex
4C: Microbiological Examination of Non-Sterile Products: Acceptance
Criteria for Pharmaceutical Preparations and Substances for
Pharmaceutical Use General Chapter. Full document...
- Annex 5: Disintegration Test General Chapter. Full document...
Guidance for Industry: Labeling OTC Skin Protectant Drug Products
This draft guidance is intended to describe the drug monograph for over-the-counter (OTC) skin protectant drug products, found in 21 CFR part 347. This guidance is intended to help interested parties understand the monograph for OTC skin protectant drug products and meet the requirements of the monograph. Full Document...
Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
This guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other post-marketing report. Full document...
Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions June 2008
This guidance is directed at questions regarding microbiological data requirements for FAPs, FCNs, and TOR requests that are unique to the use of antimicrobial food additives and food contact substances. This guidance will assist petitioners and notifiers in designing studies to determine whether an antimicrobial food additive achieves its intended technical effect. 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 Cells, Tissues, and Cellular and Tissue-Based Products; Request for Data (Federal Register)
The draft guidance provides recommendations for testing of donations of Whole Blood and blood components and HCT/P donor specimens for West Nile Virus (WNV) using an FDA-licensed donor screening assay. Full document...
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