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FDA Links -- About CDER/FDA News
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Approved Risk Evaluation and Mitigation Strategies (REMS)
(Updated: 9/1/2010)
- FDA Drug Safety Communication: Increased
risk of death with Tygacil (tigecycline) compared to other antibiotics
used to treat similar infections (9/1/2010)
- Rulemaking History for Nonprescription
Products:
Labeling of Drug Products (Updated: 9/1/2010)
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Postmarket Requirements and Commitments Download File (updated
8/31/2010)
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CDER Small Business Page
(updated 8/23/2010)
- FDA Drug Safety Podcast for
Healthcare Professionals:
Ongoing Safety Review of Stalevo and possible increased
cardiovascular risk (8/23/2010)
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Podcast for Healthcare Professionals:
Aseptic meningitis associated with use of Lamictal
(8/19/2010)
- Podcast for Healthcare
Professionals:
Serious medication errors from intravenous administration
of nimodipine oral capsules (8/19/2010)
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PDUFA Drug User Fee Act (PDUFA): FY
2011 Product and Establishment Fee Invoices were mailed Tuesday,
8/17/2010. Full payment of the invoice is due October 1, 2010.
If you do not receive your invoice by 8/27/2010, please contact
Ashley Jones or Beverly Friedman at 301-796-3602
(updated
8/18/2010)
- FDA Drug Safety Podcast:
Aseptic meningitis associated with use of Lamictal
(8/16/2010)
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FDA Proposes Withdrawal of Low Blood Pressure Drug
(8/16/2010)
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Complete List of Currently Approved NDA and
ANDA Application Submissions (PDF -
62KB) (Updated: 8/12/2010)
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Complete List of Currently Approved Premarket
Approvals (PMAs) (PDF - 27KB) (Updated: 8/12/2010)
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Complete List of Substantially Equivalent
510(k) Device Applications (PDF -
375KB) (Updated: 8/12/2010)
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Complete List of Licensed Products and
Establishments (Updated: 8/12/2010)
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Drug Safety Oversight Board Meeting, July
15, 2010, Public Summary (8/11/2010)
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Dear Healthcare Provider: Risk of thrombotic
and thromboembolic events following infusion of FEIBA VH or FEIBA NF (PDF
- 39KB) (Posted: 8/9/2010)
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FEIBA NF (Anti-Inhibitor Coagulant Complex) Approval
Letter and Package Insert (Posted: 8/9/2010)
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7342.007 Addendum - Imported Human Cells,
Tissues, and Cellular and Tissue-based Products (HCT/Ps) (Updated:
8/9/2010)
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7342.007 - Imported CBER-Regulated Products (Updated:
8/9/2010)
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FDA Drug Info Rounds: Proton Pump Inhibitors (PPIs) (8/9/2010)
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Questions and Answers on Current Good
Manufacturing Practices, Good Guidance Practices, Level 2 Guidance -
Holding and Distribution (8/9/2010)
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CDER Ombudsman (Updated: 8/5/2010)
- FDA Drug Safety Communication:
Serious medication errors from intravenous administration
of nimodipine oral capsules
(8/2/2010)
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MedWatch Alert: NeoProfen (ibuprofen lysine)
Injection: Recall and Shortage - Risk of Particulate Matter
(8/2/2010)
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MedWatch Alert: Nutraloid Labs ejaculoid
XXTREME and stimuloid II: Undeclared Drug Ingredient
(8/2/2010)
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FDA Approves Drug for Chronic Drooling in
Children (7/29/2010)
- FDA Drug Safety Communication:
Eosinophilic pneumonia associated with the use of Cubicin
(daptomycin) (7/29/2010)
- FDA Drug Safety Communication:
Ongoing safety review of Evamist (estradiol transdermal
spray) and unintended exposure of children and pets to topical estrogen
(7/29/2010)
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FDA
Statement on Avandia TIDE Trial (7/21/2010)
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MedWatch Alert: Vialipro Dietary Supplement:
Recall-Undeclared Drug Ingredient (7/20/2010)
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MedWatch Alert: Slim- 30 Herb Supplement:
Undeclared Drug Ingredient (7/20/2010)
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Medication Guides (updated
7/16/2010)
- FDA Drug Safety Communication:
Ongoing safety review of the angiotensin receptor
blockers and cancer (7/15/2010)
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Inactive Ingredient Search (updated
7/15/2010)
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MedWatch Alert: Coumadin 1 mg Tablet Blister
Packs: Recall (7/14/2010)
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FDA Drug Safety Communication:
New boxed warning for severe liver injury with arthritis drug Arava (leflunomide) (7/13/2010)
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Clinical Investigator Inspection List (CLIIL)
(updated
7/9/2010)
- Manual of Policies and Procedures
(Mapp)
4151.3r3 (PDF - 164KB) Drug Safety Oversight Board (DSB) (7/9/2010)
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FDA Drug Safety Communication:
New risk management plan and patient Medication Guide for
Qualaquin (quinine sulfate) (7/8/2010)
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FDA Approves First Generic Effexor Extended Release
Capsules to Treat Major Depressive Disorder (6/31/2010)
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Medication Health Fraud
(6/30/2010)
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Approved Risk Evaluation and Mitigation Strategies (REMS) (updated
6/30/2010)
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The Past, Present, and Future of FDA Human
Drug Regulation (6/28/2010)
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Rulemaking History for Nonprescription
Products:
Time and Extent Applications (updated 6/23/2010)
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Prescription Drug User Fee Act (PDUFA) IV
Drug Safety Five-Year Plan - 2009 Update (Updated 6/21/2010)
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FDA Warns About Fraudulent Tamiflu (6/17/2010)
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FDA Approves New Treatment for Advanced
Prostate Cancer (6/17/2010)
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Postmarketing Drug Safety Evaluations (Posted: 6/15/2010)
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PDUFA:
Federal Register Notice - Meetings on Reauthorization;
Request for Notification of Stakeholder Intention to Participate (PDF -
51KB) (6/8/2010)
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Rulemaking History for Nonprescription
Products:
General Labeling Requirements (updated 6/4/2010)
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Approved Risk Evaluation and Mitigation Strategies (REMS)(updated
6/1/2010)
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FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal
Women (6/1/2010)
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FDA Drug Safety Communication:
Drug labels now contain updated recommendations on the appropriate use
of long-acting inhaled asthma medications called Long-Acting
Beta-Agonists (LABAs) (6/1/2010)
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FDA Public Health Alert: Healthcare Professionals Warned Not To Use
Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due To
Potential Contamination
(updated)
Updated to specify the recalled products sold under the Sagent and
West-Ward labels (6/1/2010)
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FDA Public Health Alert: Healthcare
Professionals Warned Not To Use Certain Intravenous Metronidazole,
Ondansetron, and Ciprofloxacin Due To Potential Contamination
(5/29/2010)
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MedWatch Alert: Hylenex recombinant (hyaluronidase human
injection): Recall (5/27/2010)
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Questions and Answers for the Public:
Warning not to use Arrow Brand Medicated Oil & Embrocation, Aceite
Medicinal La Flecha, or "箭嘜驅風油"
(5/27/2010)
- FDA Drug Safety Communication:
Completed safety review of Xenical/Alli (orlistat) and severe liver
injury (5/26/2010)
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Questions and Answers: Orlistat and Severe Liver Injury (5/26/2010)
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