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December 11, 2009
December 10, 2009
- FDA Orphan Drugs Workshops, February 25-26, 2010, Claremont, CA; August 3-4, 2010, Minneapolis, MN. Meeting Brochure (PDF - 91 KB)
- MedWatch Alert: Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging
- New Drug Review: 2009 Update, presentation by John K. Jenkins, M.D. Director, Office of New Drugs (PDF - 514 KB)
- December 9, 2009
- Drugs@FDA Download File (updated)
- First-Time Generic Drug Approvals for October 2009
- First-Time Generic Drug Approvals for November 2009
- Guidance for Industry: PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399 KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Paragraph IV Patent Certifications (updated)
- Positron Emission Tomography (PET) (updated)
- Prescription Drug User Fee Act: FY 2009 Clean-up Product and Establishment Fee Invoices were mailed on 12/9/2009
December 8, 2009
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December 10, 2009
- Alfuzosin Hydrochloride Extended-Release Tablets, Torrent Pharma Inc., Tentative Approval
- Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco Puerto Rico, Inc., Labeling Revision
- Azilect (rasagiline mesylate) Tablets, Teva Pharmaceutical, Labeling Revision
- Hydromorphone Hydrochloride Tablets, Lannett Holdings, Inc., Approval
- Paclitaxel Injection, Actavis Totowa LLC, Approval
- Tramadol Hydrochloride and Acetaminophen Tablets, Amneal Pharmaceuticals, Approval
- Zestril (lisinopril) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision
December 9, 2009
- Gemcitabine Injection, Teva Parenteral Medicines, Inc., Tentative Approval
- Levetiracetam Tablets, Mylan Pharmaceuticals Inc., Approval
- Rosiglitazone Maleate Tablets, Hikma Pharmaceuticals, Tentative Approval
- Zyvox (linezolid) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
- Zyvox (linezolid) Injection, Pfizer Global Pharmaceuticals, Labeling Revision
- Zyvox (linezolid) Oral Suspension, Pfizer Global Pharmaceuticals, Labeling Revision
December 7, 2009
- Chloroquine Phosphate Tablets, Ohm Laboratories, Inc., Approval
- Fentora (fentanyl citrate) Tablet, Cephalon, Inc., Labeling Revision
- Fosphenytoin Sodium Injection, Hikma Farmaceutica, Approval
- Levofloxacin Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Efficacy Supp. w/Clinical Data
- Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Efficacy Supp. and Labeling Revision
- Vyvanse (lisdexamfetamine dimesylate) Capsules, Shire Pharmaceuticals, Labeling Revision
- Zyprexa (olanzapine) Tablets, Eli Lilly and Company, Efficacy Supp. w/Clinical Data
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- FDA Orphan Drugs Workshops, February 25-26, 2010, Claremont, CA; August 3-4, 2010, Minneapolis, MN. Meeting Brochure (PDF - 91 KB)
- Indexing Labeling for Human Drug and Biological Products using Structured Product Labeling (SPL). February 2010.
- FDA/DIA 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making, February 2-4, 2010, Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD. 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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Guidance
Approved Drugs
Approval Process
Electronic Submissions
Firm Registration Status
Good Manufacturing Practice
Regulations
National Drug Code Directory
MedWatch: Adverse Event
Reporting
Download Forms
Generic Drugs
Small Business
En
Espaρol
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About CBER
CBER Vision & Mission
Biologics Research, Regulatory Information, Safety & Availability, Guidances, Development & Approval, Enforcement & Compliance
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Documents frequently requested through the Freedom of Information Act.
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RULES |
New
Animal Drugs; Change of
Sponsor:
Azaperone
6568965690 [E929494]
[TEXT] [PDF]
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PROPOSED RULES |
Postmarketing Safety
Reporting for Combination
Products; Extension of
Comment Period
65702 [E929493]
[TEXT] [PDF]
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RULES |
Current Good Manufacturing
Practice for Positron
Emission Tomography Drugs
6540965436 [E929285]
[TEXT] [PDF]
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NOTICES |
Guidance on Current Good
Manufacturing Practice for
Positron Emission Tomography
Drugs; Availability
6553865539 [E929286]
[TEXT] [PDF]
Pilot Project:
Electronic Margin of Safety and NonClinical Toxicology
Study Data Submission
6554065541 [E929419]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
Approved Tobacco Retailer
Training Program; Request
for Comments
6512965130 [E929288]
[TEXT] [PDF]
Guidance for Industry on
Patient-Reported Outcome
Measures:
Use in Medical Product Development To Support Labeling
Claims; Availability
6513265133 [E929273]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES
- NONE |
Meetings:
Anesthetic and Life Support Drugs Advisory Committee
64702 [E929211]
[TEXT] [PDF]
Oncologic Drugs Advisory Committee
6470164702 [E929208]
[TEXT] [PDF]
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RULES
- NONE |
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NOTICES |
Filing of Food Additive
Petition (Animal Use)
Kemira Oyj; Formic Acid
64091 [E929049]
[TEXT] [PDF]
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