• CDER Manual of Policies and Procedures (MaPP) 4641.3R Outside Activities
• FDA issues an Information for Healthcare Professionals sheet for Amiodarone and Simvastatin. Drug Information.
• Genomics at FDA (updated)
  • Presentations
  • Publications by FDA Staff
  • Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels
• New and Generic Drug Approvals
  • Alendronate Sodium Tablets, Apotex, Inc., Approval
  • Alendronate Sodium Tablets, Aurobindo Pharma, Ltd., Approval
  • Alendronate Sodium Tablets, Barr Laboratories, Inc., Labeling
  • Alendronate Sodium Tablets, Cobalt Laboratories, Inc., Approval
  • Alendronate Sodium Tablets, Dr. Reddy's Laboratories, Ltd., Approval
  • Alendronate Sodium Tablets, Dr. Reddy's Laboratories, Ltd., Approval
  • Alendronate Sodium Tablets, Mylan Pharmaceuticals, Inc., Approval
  • Alendronate Sodium Tablets, Watson Laboratories, Inc., Approval
  • Aleve Cold and Sinus (naproxen sodium and pseudoephedrine hydrochloride) Extended-Release Tablets, Bayer Healthcare, LLC, Labeling Revision
  • Cleviprex (clevidipine butyrate) Injectable Emulsion, The Medicines Co., Approval
  • Eplerenone Tablets, Sandoz, Inc., Approval
  • Retisert (fluocinolone acetonide) Intravitreal Implant, Bausch & Lomb, Inc., Efficacy Supplement with Clinical Data to Support
  • Symlin (pramlintide acetate) Subcutaneous Injection, Amylin Pharmaceuticals, Inc. Labeling Revision
• Pediatric Research Equity Act (PREA) Labeling Changes (updated)

August 7, 2008

• BPCA/Pediatric Exclusivity Statistics:
  • Pediatric Exclusivity Granted (updated)
  • Written Requests Issued (updated)
  • Written Requests Statistics (updated)
• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Adenosine Injection, Teva Parenteral Medicines, Approval
  • Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Control Supplement
  • Cardene (nicardipine hydrochloride) Injection, EKR Therapeutics, Inc., Formulation Revision
  • Ceftriaxone (ceftriaxone sodium) Intramuscular I.V. Injection, Aurobindo Pharma Ltd., Approval
  • Diovan HCT (valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., New or Modified Indicatiion
  • Divalproex Sodium Delayed-Release Tablets, Wockhardt USA, Inc., Approval
  • Dorzolamide Hydrochloride Ophthalmic Solution, Apotex Corp., Tentative Approval
  • Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Apotex Corp., Tentative Approval
  • Lupron Depot-Ped (leuprolide acetate) Injection, Abbott Laboratories, Labeling Revision
  • Ranitidine (ranitidine hydrochloride) Tablets, Wockhardt USA, Inc., Approval

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] or [HTML]
• 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

CDER Drug Links

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Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications
Posted: 8/7/2008

Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
Posted: 8/7/2008

Supplement Approval: Pneumococcal Vaccine, Polyvalent (Pneumovax 23)
Posted: 8/7/2008, Approval Date: 8/6/2008

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
Posted: 8/7/2008

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers
Posted: 8/7/2008

Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings
Posted: 8/7/2008

Guidance for Industry: Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members
Posted: 8/7/2008

Draft Guidance for the Public and FDA Staff: Convening Advisory Committee Meetings
Posted: 8/7/2008

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
Posted: 8/7/2008

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
Posted: 8/7/2008

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
Posted: 8/7/2008

ICH; Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 5: Disintegration Test General Chapter
Posted: 8/7/2008

CBER Organizational Information - Update
Posted: 8/6/2008

Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 8/6/2008

ICH; Draft Guideline: E2F Development Safety Update Report
Posted: 8/5/2008

FDA News: FDA Approves 2008-2009 Flu Vaccines
Posted: 8/5/2008

Supplement Approval: Influenza Virus Vaccine (Afluria)
Posted: 8/5/2008, Approval Date: 7/30/2008

Supplement Approval: Influenza Virus Vaccine (Fluvirin)
Posted: 8/5/2008, Approval Date: 8/1/2008

Supplement Approval: Influenza Virus Vaccine (Fluarix)
Posted: 8/5/2008, Approval Date: 8/4/2008

Draft Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
Posted: 8/5/2008

Danger Giving Topical Thrombin Intravascularly
Posted: 8/4/2008

CBER Links

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August 7, 2008 Guidance for Industry and FDA Staff: Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter Federal Register: Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications   August 5, 2008 510(k) Final Decisions - July 2008 Federal Register: Humanitarian Device Exemption Regulation: Draft Guidance for Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Questions and Answers   August 4, 2008 Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers

Medical Device Links

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