Recent FDA Links
 

1. Public Workshop: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products, October 26-27, 2010, Arlington, VA (9/2/2010)
    
2. Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (Updated: 9/2/2010): 
   1. Annex 11 Capillary Electrophoresis General Chapter
       

1. 7341.002 - Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (Updated: 9/1/2010)
    
2. Approved Risk Evaluation and Mitigation Strategies (REMS) (Updated: 9/1/2010)
    
3. FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections (9/1/2010)
    
4. Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (Updated: 9/1/2010):
   1. Annex 12 Analytical Sieving General Chapter (PDF - 88KB)
       
5. Rulemaking History for Nonprescription Products: Labeling of Drug Products (Updated: 9/1/2010)
    
6. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (Updated: 9/1/2010)
    
7. National Drug Code Database (Updated: 9/1/2010)
    

1. Waivers for Conflicts of Interest for the September 21, 2010 Vaccines and Related Biological Products Advisory Committee Meeting (Posted: 8/31/2010)
    
2. September 21, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Draft Agenda (Posted: 8/31/2010)
    
3. September 21, 2010: Vaccines and Related Biological Products Advisory Committee Roster (Posted: 8/31/2010)
    
4. September 21, 2010: Vaccines and Related Biological Products Advisory Committee Temporary Voting Members (Posted: 8/31/2010)
    
5. Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated 8/31/2010)
    
6. Medication Guides (updated 8/31/2010)
    
7. Postmarket Requirements and Commitments Download File (updated 8/31/2010)
    

1. Guidance for Industry: Individual Product Bioequivalence Recommendations (26 Newly Added Recommendations; 10 Revised Recommendations) (Updated: 8/30/2010)
    
2. 2010 Biological Device Application Approvals (Updated: 8/30/2010)
    
3. SOPP 8413: Postmarketing Commitment Related Submissions - Administrative Handling, Review, and CBER Reporting (2) (Updated: 8/30/2010)
    

1. Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations (Posted: 8/27/2010)
    
2. Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing, September 27-28, 2010, FDA White Oak Campus, Silver Spring, Maryland. Meeting information (8/27/2010)
    
3. Generic Drug User Fee; Public Meeting; Request for Comments, September 17, 2010, Hilton Washington DC/Rockville and Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852. Meeting information (8/27/2010)
    

1. Guidance for Industry: Acute Bacterial Skin and Skin Structure Infections:  Developing Drugs for Treatment (PDF - 516kb) (Updated: 8/26/2010)
    

1. URGENT - Voluntary Market Withdrawal of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation (Posted: 8/25/2010)
    
2. Influenza Virus Vaccine for the 2010-2011 Season (Updated: 8/25/2010)
    
3. Drugs@FDA Download File (Updated: 8/25/2010)
    
4. Drug Shortages: Current Drug Shortages: Succinylcholine injection (Updated: 8/25/2010)
    
5. Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (Updated: 8/25/2010)
    

1. Guidance for Industry: Electronic Submission of Lot Distribution Reports for Biological Products (PDF - 57KB)  August 2010 (Posted: 8/24/2010)
    
2. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 8/24/2010)
    
3. Paragraph IV Patent Certifications (updated 8/24/2010)
    

1. CDER Small Business Page (updated 8/23/2010)
    
2. FDA Drug Safety Podcast for Healthcare Professionals: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk (8/23/2010)
    

1. FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk (8/20/2010)
    
2. Drug Shortages: Current Drug Shortages: Morphine Injection (2 mg, 4 mg, 8 mg, and 10 mg) (8/20/2010)
    

1. Podcast for Healthcare Professionals:  Aseptic meningitis associated with use of Lamictal (8/19/2010)
    
2. Podcast for Healthcare Professionals:  Serious medication errors from intravenous administration of nimodipine oral capsules (8/19/2010)
    
3. BPCA/Pediatric Exclusivity Statistics:
   • Pediatric Exclusivity Granted (Updated: 8/19/2010)
      
4. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (Updated: 8/19/2010)
    
5. Influenza Virus Vaccine for the 2010-2011 Season (Updated: 8/19/2010)
    

1. 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)
    

1. Guidance for Industry:  Organ-Specific Warnings:  Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide (PDF - 177KB) (updated 8/17/2010)
    

1. FDA Drug Safety Podcast: Aseptic meningitis associated with use of Lamictal (8/16/2010)
    
2. FDA Proposes Withdrawal of Low Blood Pressure Drug (8/16/2010)
    
3. Medication Guides (updated 8/16/2010)
    
4. Drug Shortages: Current Drug Shortages: Naloxone Injection (updated 8/16/2010)
    
5. Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated 8/16/2010)
    

1. FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine) (8/12/2010)
    
2. FDA Drug Safety Podcast: Avoid Unintentional Exposure of Children and Pets to Evamist (8/12/2010)
    
3. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (Updated: 8/12/2010)
    
4. SOPP 8116: Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff (Updated: 8/12/2010)
    
5. Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 62KB) (Updated: 8/12/2010)
    
6. Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 27KB) (Updated: 8/12/2010)
    
7. Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 375KB) (Updated: 8/12/2010)
    
8. Complete List of Licensed Products and Establishments (Updated: 8/12/2010)
    

1. July 26-27, 2010: Meeting of the Blood Products Advisory Committee Presentations (Posted: 8/11/2010)
    
2. Recall of Verax Biomedical Platelet PGD Test Devices, P100T (Posted: 8/11/2010)
    
3. Influenza Virus Vaccine for the 2010-2011 Season (Updated: 8/11/2010)
    
4. Drug Safety Oversight Board Meeting, July 15, 2010, Public Summary (8/11/2010)
    
5. Drugs@FDA Download File (Updated: 8/11/2010)
    

1. Recall of Panoscreen lll Immucor, Inc. (Posted: 8/10/2010)
    

1. Dear Healthcare Provider: Risk of thrombotic and thromboembolic events following infusion of FEIBA VH or FEIBA NF (PDF - 39KB) (Posted: 8/9/2010)
    
2. FEIBA NF (Anti-Inhibitor Coagulant Complex) Approval Letter and Package Insert (Posted: 8/9/2010)
    
3. 7342.007 Addendum - Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) (Updated: 8/9/2010)
    
4. 7342.007 - Imported CBER-Regulated Products (Updated: 8/9/2010)
    
5. FDA Drug Info Rounds: Proton Pump Inhibitors (PPIs) (8/9/2010)
    
6. CDER's Small Business Assistance Educational Forum: The Investigational New Drug (IND) Process, October 8, 2010, National Labor College (NLC), George Meany Campus, Silver Spring, MD. (8/9/2010)
    
7. Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Holding and Distribution (8/9/2010)
    

1. SOPP 8401.3: Filing Action: Communication Options (Updated: 8/6/2010)
    
2. BPCA/Pediatric Exclusivity Statistics (Updated: 8/6/2010):
   1. Pediatric Exclusivity Statistics
   2. Written Requests Issued
       

1. AAPS Workshop on Advances and Opportunities in Drug Product Manufacturing, September 20 - 21, 2010, Sheraton Inner Harbor Hotel, Baltimore, MD. Meeting information and registration (8/5/2010)
    
2. CDER Ombudsman (Updated: 8/5/2010)
    
3. SOPP 8104: Documentation of Telephone Contacts with Regulated Industry (Updated: 8/5/2010)
    
4. 2010 Biological License Application Approvals (Updated: 8/5/2010)
    
5. 2010 Biological License Application Supplement Noteworthy Approvals (Updated: 8/5/2010)
    
6. 2010 Biological Device Application Approvals (Updated: 8/5/2010)
    

1. Influenza Virus Vaccine for the 2010-2011 Season (Updated: 8/4/2010)
    
2. Guidance for Industry (Updated: 8/4/2010):
   1. Comprehensive List of Guidance Documents (PDF - 740KB)
   2. New/Revised Withdrawn List of Guidances for 2010 (PDF - 80KB)
       
3. Design of Clinical Trials of Aerosolized Antimicrobials for the Treatment of Cystic Fibrosis; Public Workshop, September 23-24, 2010, Crowne Plaza Hotel, 8777 Georgia Avenue, Silver Spring, Maryland 20910. Meeting information (8/4/2010)
    
4. Podcast for Healthcare Professionals: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin) (8/4/2010)
    
5. Podcast for Healthcare Professionals: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen (8/4/2010)
    
6. Prescription Drug User Fee Act (PDUFA): Establishment of Prescription Drug User Fee Rates for Fiscal Year 2011 (PDF - 64KB) (Updated: 8/4/2010)
    
7. The Adverse Event Reporting System (AERS): Latest Quarterly Data Files (Updated: 8/4/2010)
    
8. Drug Shortages: Current Drug Shortages: Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s (Updated: 8/4/2010)
    

1. Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products (PDF - 148KB) (8/3/2010)
    
2. Postmarket Requirements and Commitments (8/3/2010)
    

1. FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules (8/2/2010)
    
2. MedWatch Alert: NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter (8/2/2010)
    
3. MedWatch Alert: Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient (8/2/2010)
    
4. National Drug Code Database (updated 8/2/2010)
    

1. Guidance For Industry: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 417KB) (7/30/2010)
    

1. FDA Approves Drug for Chronic Drooling in Children (7/29/2010)
    
2. FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin) (7/29/2010)
    
3. 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)
    
4. Risk Evaluation and Mitigation Strategy (REMS) Public Meeting, July 27-28, 2010, archived meeting webcast (7/29/2010)
    

1. FluLaval Influenza Virus Vaccine, Package Insert, Approval Letter (Updated: 7/27/2010)
    
2. Fluzone and Fluzone High-Dose Influenza Virus Vaccine, Package Insert, Approval Letter (Updated: 7/27/2010)
    
3. FluMist Influenza Vaccine Live, Intranasal Package Insert, Approval Letters (Updated: 7/27/2010)
    
4. Drug Shortages: Current Drug Shortages: NeoProfen (ibuprofen lysine) Injection (updated 7/27/2010)
    

1. Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated 7/23/2010)
    

1. Breakdown of FDAAA Completed Pediatric Studies (updated 7/22/2010)
    

1. FDA Statement on Avandia TIDE Trial (7/21/2010)
    
2. February 22, 2010: Vaccines and Related Biological Products Advisory Committee Transcripts (PDF - 193KB)  (Posted: 7/21/2010)
    
3. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 7/21/2010)
    

1. MedWatch Alert: Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient (7/20/2010)
    
2. MedWatch Alert: Slim- 30 Herb Supplement: Undeclared Drug Ingredient (7/20/2010)
    

1. ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents (updated 7/19/2010)
   1. Draft Recommendation for the Revision of the Permitted Daily Exposure for Cumene According to the Maintenance Procedures for Q3C Impurities: Residual Solvents
       

1. Medication Guides (updated 7/16/2010)
    

1. FDA Drug Safety Communication: Ongoing safety review of the angiotensin receptor blockers and cancer (7/15/2010)
    
2. Inactive Ingredient Search (updated 7/15/2010)
    
3. Drug Shortages: Current Drug Shortages: Calcium Chloride Injection (updated 7/15/2010)
    
4. Drug Shortages: Current Drug Shortages: Levorphanol 2mg Tablets (updated 7/15/2010)