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      Archived Info:  Recent FDA Links
                              FDA Links by Classification
 

• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated 3/17/2010)
   
• 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)
   
• Drug Shortages: Current Drug Shortages: Oxsoralen (methoxsalen) 1% topical lotion (3/17/2010)
   
• Drug Shortages: Current Drug Shortages: Oxsoralen-Ultra (methoxsalen) 10 mg capsules (3/17/2010)
   
• Generic Drug Petition Tracking: Suitability Tracking Reports (updated 3/16/2010)
   
• 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
      
• Medication Guides  (updated 3/16/2010)
   
• Statement to Healthcare Professionals on the ACCORD Lipid Trial from the FDA’s Center for Drug Evaluation and Research (3/15/2010)
   
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 185KB) (Updated: 3/15/2010)
   
• Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 48KB) (Updated: 3/15/2010)
   
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 885KB) (Updated: 3/15/2010)
   
• Biologic Product Shortages (Updated: 3/15/2010)
   
• Complete List of Licensed Products and Establishments (Updated: 3/15/2010)
   
• FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug (3/12/2010)
   
• Market Withdrawal of Chiron RIBA HCV 3.0 SIA (Posted: 3/12/2010)
   
• FY 2008 Annual Report: Innovative Technology Advancing Public Health (Posted: 3/11/2010)
   
• Pediatric Drug Development: Notice of Pediatric Formulations Not Marketed (PDF - 18KB) (3/11/2010)
   
• Drug Shortages: Current Drug Shortages: Propofol Injection (updated 3/11/2010)
   
• FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures (3/10/2010)
   
• FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers (3/10/2010)
   
• BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Statistics (updated 3/10/2010)
   
• Drugs@FDA Download File (updated 3/10/2010)
   
• Realignment in the Office of New Drugs (3/9/2010)
   
• Guidance for Industry:  S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 170 KB) (3/5/2010)
   
• Office of Nonprescription Products Consumer Update: Hydroquinone Studies Under The National Toxicology Program (NTP) (3/5/2010)
   
• FDA Approves Name Change for Heartburn Drug Kapidex (3/4/2010)
   
• Follow-up letters to 6 companies marketing unapproved narcotics containing morphine sulfate (3/4/2010)
   
• Manual of Policies and Procedures (CDER MaPP) 7400.11 Management of the PTCC Nonclinical Biologics Subcommittee (PDF - 54 KB) (3/4/2010)
   
• Workshops, Meetings & Conferences (Biologics) DIA/FDA CDER/CBER Computational Science Annual Meeting (Posted: 3/4/2010)
   
• First-Time Generic Drug Approvals for February 2010 (3/4/2010)
   
• First-Time Generic Drug Approvals for January 2010 (3/4/2010)
   
• FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland (3/3/2010)
   
• 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)
   
• Influenza Virus Vaccine for the 2010-2011 Season (Posted: 3/2/2010)
   
• Drug Shortages: Current Drug Shortages: Cerezyme (imiglucerase) Injection (updated 3/2/2010)
   
• Approved Risk Evaluation and Mitigation Strategies (REMS) (updated 3/1/2010)
   
• Drug Shortages: Current Drug Shortages: Propofol Injection (updated 3/1/2010)
   
• 2009 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals (Updated: 2/26/2010)
   
• 2009 Biological License Application Supplement Noteworthy Approvals (Updated: 2/26/2010)
   
• 2010 Biological Device Application Approvals (Updated: 2/26/2010)
   
• Guidance for Industry: Non-Inferiority Clinical Trials (PDF - 565 KB) (updated 2/26/2010):
   
• 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)
   
• FDA Expands Commitment to Patients with Rare Diseases (2/25/2010)
   
• 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
      
• Drug Shortages: Current Drug Shortages: Ephedrine Injection (2/25/2010)
   
• Drug Shortages: Resolved Drug Shortages: Erythromycin Ophthalmic Ointment (2/25/2010)
   
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 2/24/2010)
   
• FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms (2/23/2010)
   
• Paragraph IV Patent Certifications  (updated 2/23/2010)
   
• Drug Safety Oversight Board Meeting, Public Summary, January 21, 2010 (2/22/2010)
   
• FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety (2/22/2010)
   
• Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (2/22/2010)
   
• Orange Book: January 2010: Additions and Deletions to the Drug Product List (PDF - 121KB) (2/22/2010)
   
• Recent FDA Links
• FDA Links by Classification
  
   

      Archived Info:  Recently Issued US Federal Register
 

      Archived Info: 
     Recently Issued FDA Warning/Notice of Violation Letters
     Warning/Notice of Violation Letters Indexed by Company Names
 

• Meda Pharmaceuticals, Inc. (ASTELIN®(azelastine hydrochloride) Nasal Spray)
   
• Sanofi-Aventis U.S. LLC (BenzaClin® (clindamycin 1% - benzoyl peroxide 5%) gel)
   
• Novalar Pharmaceuticals, Inc. (OraVerse (phentolamine mesylate) Injection)
   
• Baumann Cosmetic and Research Institute (Dysport (abobotulinumtoxinA) for Injection)
   
• Bracco Diagnostics, Inc. (Isovue® (iopamidol injection))
   
• GE Healthcare (Visipaque ^TM (iodixanol) Injection)
   
• Eli Lilly and Company (Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral Use)
   
• Bayer HealthCare Pharmaceuticals, Inc. (Mirena® (levonorgestrel-releasing intrauterine system))
   
• Amylin Pharmaceuticals, Inc. (Byetta® (exenatide) injection)
   
• Cephalon, Inc. (Treanda® (bendamustine hydrochloride) for Injection)
   
• Recently Issued FDA Warning Letters
• Warning Letters Indexed by Company Names
   

First Page:  Patents/News etc.
(Patents ; News ; Stock Quotes)
 

 New! Training Courses
 New! Web Seminars

• Introduction to Effective Medical Writing  April 22 - 23, 2010, Berlin, Germany.  Organized by The Center for Professional Innovation & Education.  (Other CfPIE Training Courses)
   
• Web Seminar: How to Use the FCC Forum  On-Demand Recording.  Organized by USP (United States Pharmacopeia). (Other USP Web Seminars)
   
• Web Seminar: A Quality Management Systems Approach to Pharmaceutical cGMP Regulations and Inspections  April 9, 2010.  Instructor: Kerry P. Potter.  Organized by BenAstrum, Inc. Use promotional code PC0410 for 10% discount. (Other BenAstrum's Web Seminars)
   
• SFE Europe 2010  April 27 - 29, 2010, Barcelona, Spain.  Organized by eyeforpharma.
   
• Controlled Release  April 28 - 29, 2010, London, UK.  Organized by SMi Group Ltd.
   
• 4th Annual Paragraph IV Disputes  April 28 - 29, 2010, New York, NY.  Organized by American Conference Institute.
   
• 11th Investigator Initiated Trials  April 29 - 30, 2010, Arlington, VA.  Organized by ExL Pharma.  Organized by ExL Pharma.
   
• Generics, Super-Generics and Patent Strategies  May 10 - 11, 2010, London, UK.  Organized by SMi Group Ltd.
   
• PharmaMarketing Summit 2010  May 10 - 12, 2010, Miami, FL.  Organized by Marcus Evans.
   
• Evolution Summit 2010  May 10 - 12, 2010, Miami, FL.  Organized by Marcus Evans.
   
• Other Pharmaceutical and Biotech Events

 

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First Page:  Patents/News etc.
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