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November 6, 2009
November 5, 2009
November 4, 2009
November 3, 2009
November 2, 2009
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November 6, 2009
- Clinimix 2.75/10 Sulfite Free in Dextrose (amino acids and dextrose) Injection, Baxter Healthcare, Labeling Revision
- Clinimix E 5/25 Sulfite Free with Elect in Dextrose (amino acids, calcium chloride, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, and sodium chloride) Injection, Baxter Healthcare, Labeling Revision
- Istodax (romidepsin) Single-Use Vial, Gloucester Pharmaceuticals, Inc., Approval
- Reyataz (atazanavir sulfate) Capsules, Bristol Myers Squibb, Efficacy Supplement with Clinical Data to Support
November 5, 2009
- Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, Efficacy Supp. w/Clinical Data
- Entereg (alvimopan) Capsules, Adolor Corporation, Labeling Revision
- Fentanyl Citrate Oral Lozenge, Mallinckrodt Inc., Approval
- ISENTRESS (raltegravir potassium) Tablets, Merck & Co., Inc., Labeling Revision
- Lialda (mesalamine) Delayed-Release Tablets, Shire Development Inc., Labeling Revision
- Lamotrigine Tablets, Aurobindo Pharma Limited, Approval
- MIACALCIN (calcitonin and salmon) Injection, Novartis Pharmaceuticals Corporation, Labeling Revision
- MIACALCIN (calcitonin and salmon) Nasal Spray, Novartis Pharmaceuticals Corporation, Labeling Revision
- Omeprazole and Sodium Bicarbonate Capsules, Par Pharmaceutical, Inc., Tentative Approval
- Relistor (methylnaltrexone bromide) Subcutaneous Injection, Progenics Pharmaceuticals, Inc., Labeling Revision
November 4, 2009
- Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Labeling Revision
- Fentanyl Citrate Oral Lozenge, Barr Laboratories, Inc., Approval
- Rosiglitazone Maleate and Glimepiride Tablets, Teva Pharmaceuticals, Tentative Approval
- Sumatriptan Succinate Tablets, Mylan Pharmaceuticals, Inc., Approval
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- Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools, November 12 and 13, 2009 Meeting information Registration for this meeting is closed. Please see meeting information for webcast instructions.
- DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010, Bethesda, MD. Meeting information and registration.
- 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration.
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- 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 (PDF - 68KB)
Posted: 11/6/2009
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Postdoctoral Fellowship (OVRR/DBPAP/LRP), Updated: 11/6/2009
- Berinert
C1 Esterase Inhibitor (Human)-Approval History,Letters, Reviews and Related Documents, Posted: 11/6/2009
- Important Registration and Listing Reminder for Manufacturers of Biological Drug Products Subject to 21 C.F.R. Part 207
Posted: 11/4/2009
- 2009 Meeting Materials of the Blood Products Advisory Committee
Briefing Documents for the November 16-17, 2009 Meeting of the Blood Products Advisory Committee, Posted 11/4/2009
- Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Lot Release Information, Updated: 11/4/2009
- Influenza Virus Vaccine for the 2009-2010 Season
Lot Release Information, Updated: 11/4/2009
- ProQuad
Approval Letter and Approved Final Draft Labeling for Merck's Efficacy Supplement for Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad)
- Jobs at the Center for Biologics Evaluation and Research (CBER)
Program Support Assistant (OM/BOS), Posted 11/3/2009
- 2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
Waivers for Conflicts of Interest for the November 18-19, 2009 Vaccines and Related Biological Products Advisory Committee Meeting, Posted 11/3/2009
- 2009 Meeting Materials of the Blood Products Advisory Committee
Waivers for Conflicts of Interest for the November 16-17, 2009 Blood Products Advisory Committee Meeting, Posted 11/2/2009
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- About CBER
- CBER Vision & Mission
Biologics Research, Regulatory Information, Safety & Availability, Guidances, Development & Approval, Enforcement & Compliance
- News & Events (Biologics)
What's New, Meetings & Workshops
- CBER Reports
CBER Annual Report, Performance, FDAMA, PDUFA, FDAAA, PREA
- Biologics Regulated Products
Allergenics, Blood & Blood Products, Cellular & Gene Therapy Products, Tissue & Tissue Products, Vaccines, Xenotransplantation
- Contacts in the Center for Biologics Evaluation & Research (CBER)
Consumer questions, manufacturer's assistance, media inquiries, technical questions, requesting speakers, establishment registration...
- Jobs at the Center for Biologics Evaluation and Research (CBER)
- Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER Regulates
- Biologics Electronic Reading Room (eFOI)
Documents frequently requested through the Freedom of Information Act.
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November 6, 2009
November 5, 2009
November 4, 2009
November 3, 2009
November 2, 2009
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RULES
- NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
5749157493 [E926760]
[TEXT] [PDF]
5749557496 [E926850]
[TEXT] [PDF]
Guidance for Industry and
Food and Drug Administration
Staff:
In Vitro Diagnostic 2009 H1N1 Tests for Use in 2009
H1N1 Emergency; Availability
5750357504 [E926737]
[TEXT] [PDF] |
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RULES |
Listing of Color Additives
Exempt From Certification:
Astaxanthin Dimethyldisuccinate
5724857251 [E926524]
[TEXT] [PDF] |
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NOTICES |
Amendment to Memorandum of
Understanding:
Food and Drug Administration and WebMD, LLC
5731657318 [E926674]
[TEXT] [PDF]
Draft Guidance for Industry:
Dosage Delivery Devices for Over-The-Counter Liquid
Drug Products; Availability
57319 [E926531]
[TEXT] [PDF]
Food and Drug
Administration's Safe Use
Initiative; Availability of
Information
5731957320 [E926530]
[TEXT] [PDF] |
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RULES
- NONE |
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NOTICES |
Draft Guidance for Industry:
Guide to Minimize Microbial Food Safety Hazards of
Leafy Greens; Extension of
Comment Period
57180 [E926637]
[TEXT] [PDF]
Guide to Minimize Microbial Food Safety Hazards of
Melons; Extension of Comment
Period
57179 [E926638]
[TEXT] [PDF]
Guide to Minimize Microbial Food Safety Hazards of
Tomatoes; Extension of
Comment Period
5717957180 [E926636]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
Draft Guidance for Industry
on Listing of Ingredients in
Tobacco Products;
Availability
5684256843 [E926466]
[TEXT] [PDF]
Meetings:
International Conference on Harmonisation S2 Genetic
Toxicology Issues; Request
for Comments
5685656857 [E926397]
[TEXT] [PDF]
Product Tracing Systems for Food
5684356855 [E926479]
[TEXT] [PDF]
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RULES - NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
5664356644 [E926290]
[TEXT] [PDF]
5664256643 [E926307]
[TEXT] [PDF]
Authorization of Emergency
Use of the Antiviral Product
Peramivir Accompanied by
Emergency Use Information
5664456649 [E926291]
[TEXT] [PDF]
Meetings:
Ear, Nose, and Throat Devices Panel of the Medical
Devices Advisory Committee
5665156652 [E926260]
[TEXT] [PDF]
Gastroenterology and Urology Devices Panel of the
Medical Devices Advisory
Committee
5665056651 [E926259]
[TEXT] [PDF]
Neurological Devices Panel of the Medical Devices
Advisory Committee;
Postponement
56655 [E926261]
[TEXT] [PDF]
Pediatric Advisory
Committee; Amendment
56652 [E926262]
[TEXT] [PDF]
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