Recent FDA Links
 

1. CDER Ombudsman's 2009 Annual Report (PDF - 44KB) (3/19/2010)
    
2. Manual of Policies and Procedures (MaPPs) 5015.5 CMC Reviews of Type III DMF's for Packaging Materials (PDF - 75 KB) (3/19/2010)
    

1. MedWatch Alert: Cleviprex (clevidipine butyrate): Recall (3/18/2010)
    
2. 2010 PDA/FDA Pharmaceutical Supply Chain Workshop - Enough Talk: Let's Find and Implement Solutions, April 26-28, 2010, Hyatt Regency Bethesda, 7400 Wisconsin Ave, 1 Bethesda Metro Center, Bethesda, MD 20814. Meeting information and registration (3/18/2010)
    

1. Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 151 KB) (updated 3/17/2010)
    
2. Orange Book: February 2010: Additions and Deletions to the Drug Product List (PDF - 210KB) (updated 3/17/2010)
    
3. Orange Book: Current Cumulative Supplement (PDF - 333KB) (updated 3/17/2010)
    
4. Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated 3/17/2010)
    
5. Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 151 KB) (updated 3/17/2010)
    
6. Drug Shortages: Current Drug Shortages: Oxsoralen (methoxsalen) 1% topical lotion (3/17/2010)
    
7. Drug Shortages: Current Drug Shortages: Oxsoralen-Ultra (methoxsalen) 10 mg capsules (3/17/2010)
    

1. Generic Drug Petition Tracking: Suitability Tracking Reports (updated 3/16/2010)
    
2. Questions and Answers for Consumers about FDA's Action Involving Unapproved Nitroglycerin Sublingual Tablets (3/16/2010)
   1. FDA News Release: FDA Orders 2 Companies to Stop Marketing Unapproved Nitroglycerin Tablets
       
3. Medication Guides  (updated 3/16/2010)
    

1. Statement to Healthcare Professionals on the ACCORD Lipid Trial from the FDA’s Center for Drug Evaluation and Research (3/15/2010)
    
2. Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 185KB) (Updated: 3/15/2010)
    
3. Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 48KB) (Updated: 3/15/2010)
    
4. Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 885KB) (Updated: 3/15/2010)
    
5. Biologic Product Shortages (Updated: 3/15/2010)
    
6. Complete List of Licensed Products and Establishments (Updated: 3/15/2010)
    

1. FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug (3/12/2010)
    
2. Market Withdrawal of Chiron RIBA HCV 3.0 SIA (Posted: 3/12/2010)
    

1. FY 2008 Annual Report: Innovative Technology Advancing Public Health (Posted: 3/11/2010)
    
2. Pediatric Drug Development: Notice of Pediatric Formulations Not Marketed (PDF - 18KB) (3/11/2010)
    
3. Drug Shortages: Current Drug Shortages: Propofol Injection (updated 3/11/2010)
    

1. FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures (3/10/2010)
    
2. FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers (3/10/2010)
    
3. BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Statistics (updated 3/10/2010)
    
4. Drugs@FDA Download File (updated 3/10/2010)
    

1. Realignment in the Office of New Drugs (3/9/2010)
    

1. Guidance for Industry:  S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 170 KB) (3/5/2010)
    
2. Office of Nonprescription Products Consumer Update: Hydroquinone Studies Under The National Toxicology Program (NTP) (3/5/2010)
    

1. FDA Approves Name Change for Heartburn Drug Kapidex (3/4/2010)
    
2. Follow-up letters to 6 companies marketing unapproved narcotics containing morphine sulfate (3/4/2010)
    
3. Manual of Policies and Procedures (CDER MaPP) 7400.11 Management of the PTCC Nonclinical Biologics Subcommittee (PDF - 54 KB) (3/4/2010)
    
4. Workshops, Meetings & Conferences (Biologics) DIA/FDA CDER/CBER Computational Science Annual Meeting (Posted: 3/4/2010)
    
5. First-Time Generic Drug Approvals for February 2010 (3/4/2010)
    
6. First-Time Generic Drug Approvals for January 2010 (3/4/2010)
    
7. Drugs@FDA Download File (updated 3/4/2010)
    

1. FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland (3/3/2010)
    

1. Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (PDF - 406KB) (Posted: 3/2/2010)
    
2. Influenza Virus Vaccine for the 2010-2011 Season (Posted: 3/2/2010)
    
3. Drug Shortages: Current Drug Shortages: Cerezyme (imiglucerase) Injection (updated 3/2/2010)
    

1. Approved Risk Evaluation and Mitigation Strategies (REMS) (updated 3/1/2010)
    
2. Drug Shortages: Current Drug Shortages: Propofol Injection (updated 3/1/2010)
    

1. 2009 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals (Updated: 2/26/2010)
    
2. 2009 Biological License Application Supplement Noteworthy Approvals (Updated: 2/26/2010)
    
3. 2010 Biological Device Application Approvals (Updated: 2/26/2010)
    
4. Guidance for Industry: Non-Inferiority Clinical Trials (PDF - 565 KB) (updated 2/26/2010):
    
5. FDA and PAT for Pharma Manufacturing: FDA-Partnering with Industry; a joint FDA/URI College of Pharmacy conference, Bethesda, Maryland, Hyatt Regency Bethesda, May 11-12, 2010. Meeting information and registration (2/26/2010)
    

1. FDA Expands Commitment to Patients with Rare Diseases (2/25/2010)
    
2. Guidance for Industry (updated 2/25/2010):
   1. Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 424 KB)
   2. Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 69 KB)
   3. Individual Bioequivalence Guidances Newly Added Recommendations
       
3. Drug Shortages: Current Drug Shortages: Ephedrine Injection (2/25/2010)
    
4. Drug Shortages: Resolved Drug Shortages: Erythromycin Ophthalmic Ointment (2/25/2010)
    

1. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 2/24/2010)
    

1. FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms (2/23/2010)
    
2. Paragraph IV Patent Certifications  (updated 2/23/2010)
    

1. Drug Safety Oversight Board Meeting, Public Summary, January 21, 2010 (2/22/2010)
    
2. FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety (2/22/2010)
    
3. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (2/22/2010)
    
4. Orange Book: January 2010: Additions and Deletions to the Drug Product List (PDF - 121KB) (2/22/2010)
    
5. Orange Book: Current Cumulative Supplement (PDF - 333KB) (2/22/2010)
    
6. Drug Shortages: Current Drug Shortages: Acyclovir Tablets and Capsules (updated 2/22/2010)
    
7. Drug Shortages: Resolved Drug Shortages: Indocin I. V. (indomethacin for injection) (2/22/2010)
    

1. MedWatch Alert - Exjade (deferasirox): Boxed Warning (2/19/2010)
    
2. Orange Book Annual 30th Edition (PDF - 16944KB) (2/19/2010)
    

1. Questions and Answers: New Safety Requirements for Long-Acting Asthma Medications called Long-Acting Beta Agonists (LABAs) (2/18/2010)
    
2. FDA Drug Safety Communication: New safety requirements for Long-Acting Inhaled Asthma Medications called Long-Acting Beta-Agonists (LABAs) (2/18/2010)
    
3. Orange Book FR Safety or Effectiveness Determinations List (PDF) (PDF - 134KB) (2/18/2010)
    
4. Drug Shortages: Current Drug Shortages: Propofol Injection (updated 2/18/2010)
    
5. Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated 2/18/2010)
    

1. 2010 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (Draft Agenda, Member Roster, Posted: 2/17/2010)
    
2. FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products (2/17/2010)
    
3. Medication Guides (updated 2/17/2010)
    
4. Drugs@FDA Download File (updated 2/17/2010)
    
5. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 2/17/2010)
    

1. The 13th US-Japan Cellular and Gene Therapy Conference on Systems Biology in Cell Cycle Regulation (Posted: 2/16/2010)
    
2. FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp (2/16/2010)
    
3. Drug Shortages: Current Drug Shortages: Heparin Sodium Large Volume Premixed Infusion Solutions (2/16/2010)
    
4. Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated 2/16/2010)
    

1. Guidance for Industry:  Individual Product Bioequivalence Recommendations (updated 2/12/2010)
    
2. Paragraph IV Patent Certifications (updated 2/12/2010)
    

1. Bioresearch Monitoring Information System Database (updated 2/10/2010)
    
2. Drugs@FDA Download File (updated 2/10/2010)
    

1. Questions and Answers for Healthcare Professionals: CRESTOR and the JUPITER Trial (2/8/2010)