From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 7 Aug 2008 05:54:11 -0500 (CDT)
Subject: CDER New 8/4 - 6/2008
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August 6, 2008
- Cyber Letters (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Approval Reports
- NDA and BLA Approvals (updated)
- NME Drug and New Biologic Approvals (updated)
- Priority NDA and BLA Approvals (updated)
- Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States [PDF]
- National Drug Code Directory (updated)
- Paragraph IV Patent Certifications (updated)
August 5, 2008
- Drug Shortages: Drugs to be Discontinued; Geref Diagnostic
- Drug Master Files (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
- Paragraph IV Patent Certifications (updated)
August 4, 2008
- Guidance for Industry: E2F Development Safety Update Report [PDF]
- Guidance for Industry: International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions;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 [PDF]
- Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter [PDF]
- Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter [PDF]
- Annex 5: Disintegration Test General Chapter [PDF]
- Guidance for Industry: Labeling OTC Skin Protectant Drug Products [PDF]
- Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes [PDF]
- Office of Generic Drugs: July First-Time Generic Drug Approvals
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 7 Aug 2008 08:47:10 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers (PDF) - 8/7/2008
Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings (PDF) - 8/7/2008
Guidance for Industry: Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members (PDF) - 8/7/2008
Draft Guidance for the Public and FDA Staff: Convening Advisory Committee Meetings (PDF) - 8/7/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF) - 8/7/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF) - 8/7/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF) - 8/7/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 5: Disintegration Test General Chapter (PDF) - 8/7/2008
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 7 Aug 2008 17:54:28 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
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