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October 30,
2009
October 29,
2009
October 28,
2009
October 27,
2009
October 26,
2009
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October 30, 2009
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- Anthelios 40 (ecamsule, avobenzone, octocrylene, and titanium dioxide) Topical Cream, LOreal USA, Efficacy Supplement with Clinical Data to Support
- Flomax (tamsulosin hydrochloride) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
- Levetiracetam Oral Solution, Amneal Pharmaceuticals, Approval
- Melphalan Hydrochloride Injection, GeneraMedix, Inc., Approval
October 29, 2009
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- ARZERRA (ofatumumab) Injection, GlaxoSmithKine, Approval
- Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharmaceuticals Corporation, Efficacy Supp. w/Clinical Data
- Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules, Novartis Pharmaceuticals Corporation, Labeling Revision
- Norpramin (desipramine hydrochloride) Tablets, Sanofi-Aventis US, Inc., Labeling Revision
- Risperidone Orally Disintegrating Tablets, Par Pharmaceutical, Inc., New Strength
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- DIA/FDA Assessing Benefits and Risks of Medicinal Products in Regulatory Decisions, November 3-5, 2009, Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland. Meeting information and registration
- 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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- 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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RULES
- NONE |
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NOTICES
- NONE |
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RULES |
Investigational New Drug
Applications; Technical
Amendment
5577055771 [E926095]
[TEXT] [PDF]
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NOTICES
- NONE |
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RULES
- NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
5555655557 [E925915]
[TEXT] [PDF]
5555755558 [E925927]
[TEXT] [PDF]
Draft Guidance for Industry
and Reviewers:
Structured Product Labeling Standard for Content of
Labeling Technical Questions
and Answers, Revision
5556255564 [E925940]
[TEXT] [PDF]
Meetings:
Science Advisory Board to the National Center for
Toxicological Research
5556455565 [E925941]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
Meetings:
Endocrinologic and Metabolic Drugs Advisory Committee
5524355244 [E925805]
[TEXT] [PDF]
Pediatric Oncology Subcommittee of the Oncologic Drugs
Advisory Committee
55243 [E925806]
[TEXT] [PDF]
Prescription Drug User Fee
Rates for Fiscal Year 2010;
Correction
55244 [E925804]
[TEXT] [PDF]
Public Workshop:
Emerging Arboviruses; Risk Assessment for Blood, Cell,
Tissue, and Organ Safety
5524455245 [E925802]
[TEXT] [PDF]
Saccharomyces boulardii
Eligibility for
Consideration to Be Added to
the Over-the-Counter Drug
Monograph for Antidiarrheal
Drug Products:
Request for Safety and Effectiveness Data; Withdrawal
5524555246 [E925803]
[TEXT] [PDF]
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RULES - NONE |
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NOTICES |
Agency Information
Collection Activities;
Proposals, Submissions, and
Approvals
5505055051 [E925604]
[TEXT] [PDF]
5504655048 [E925671]
[TEXT] [PDF]
Guidance for Industry on
Investigator
Responsibilities:
Protecting the Rights, Safety, and Welfare of Study
Subjects; Availability
5505255053 [E925629]
[TEXT] [PDF]
Meetings:
Anti-Infective Drugs Advisory Committee
5505655057 [E925627]
[TEXT] [PDF]
55057 [E925628]
[TEXT] [PDF]
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