August 21, 2009

• Drugs@FDA Download File (updated)
• Drug Shortages: Current Drug Shortages: Cerezyme (imiglucerase) Injection (updated)

Warning Letters

• Galderma Labs (Issued 8/18/09)
• Allergan Inc. (Issued 8/17/09)
• Johnson & Johnson IRB (Issued 8/10/09)
• CHRISTUS Schumpert Health System IRB (Issued 7/30/09)
• Barbara Harris, PhD (Issued 7/27/09)
• Antibioticos do Brasil Uda. (Issued 7/24/09)

August 20, 2009

• Drug Information Association (DIA) and Food and Drug Administration (FDA): Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications: Current State of the Art and Opportunities to Advance the Science, September 23-24, 2009, Omni Shoreham Hotel, Washington, DC. Meeting Information and registration
• Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated)
• The Public’s Stake in Adverse Event Reporting
• Technetium-99m Radiopharmaceutical Product Shortage (updated)

August 18, 2009

• Guidance For Industry: 21 Newly Added Individual Bioequivalence Recommendations
• Medication Guides (updated) (new: Embeda)
• Drug Shortages: Current Drug Shortages: Methotrexate injection (updated)
• Drug Shortages: Resolved Drug Shortages: Orap (pimozide) 1 mg and 2 mg Tablets
• FDA, Issues in the Development of Antiviral Products for Treatment of Smallpox and Related Poxvirus Infections; Public Workshop, September 1-2, 2009 (updated)
• Memorandum of Meeting Minutes, Drug Safety Oversight Board Meeting, July 16, 2009
• Paragraph IV Patent Certifications (updated)
• The FY 2010 Product and Establishment Fee Invoices were mailed Friday, August 14, 2009.  Full payment of the invoice is due by October 1, 2009.  If you do not receive your invoice by August 24, 2009, please contact Michael Jones or Beverly Friedman at 301-796-3602.

August 17, 2009

• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
• Voluntary recall of Dextroamphetamine, amphetamine 20mg Tablets
• Roche notifies healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept

August 20, 2009

• • Aspirin and Dipyridamole Extended-Release Capsules, Barr Laboratories Inc., Approval
  • Bisoprolol Fumarate Tablets, Unichem Laboratories Ltd., Approval
  • Clonidine Patch, Aveva Drug Delivery Systems, Inc., Approval
  • Extavia (inteneron beta-l b) Subcutaneous Injection, Novartis Pharmaceuticals Corp., Approval
  • Glycopyrrolate Tablets, Ranbaxy Laboratories Ltd., Approval
  • Penicillin G Potassium Injection, APP Pharmaceuticals, LLC, Approval
  • Zoledronic Acid Injection, Sun Pharma Global, Inc., Tentative Approval

August 18, 2009

• • Alfuzosin Hydrochloride Extended-Release Tablets, Apotex Inc., Tentative Approval
  • Dipentum (olsalazine sodium) Capsules, Alaven Pharmaceutical LLC, Supplement
  • Embeda (morphine sulfate and naltrexone hydrocholride) Extended-Release Tablets, AlPharma Pharmaceuticals, Inc/King Pharmaceuticals, Approval
  • Humulin 50/50 (insulin [rDNA origin] and insulin susp isophane [rDNA origin]) Injection, Eli Lilly and Co., Supplement
  • Letairis (ambrisentan) Tablets, Gilead Sciences, Inc., Supplement
  • Minocycline Hydrochloride Tablets, Sandoz Inc., Approval
  • Ortho Evra (ethinyl estradiol and norelgestromin) Patch, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Supplement

• FDA, Issues in the Development of Antiviral Products for Treatment of Smallpox and Related Poxvirus Infections; Public Workshop, September 1-2, 2009
• 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. Meeting Information and registration
• Drug Information Association (DIA) and Food and Drug Administration (FDA): Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications: Current State of the Art and Opportunities to Advance the Science, September 23-24, 2009, Omni Shoreham Hotel, Washington, DC. Meeting Information and registration
• Providing Effective Information to Consumers about Prescription Drug Risks and Benefits; Public Workshop, September 24-25, 2009, Gaithersburg, MD 20877. Meeting Information
• CDER Forum for International Drug Regulatory Authorities, October 5-9, 2009, Silver Spring, MD.   

• Guidance Documents (Medical Devices) 
• How to Market Your Device 
• Postmarket Requirements (Devices) 
• Importing and Exporting Devices 
• International Information (Devices) 
• Device Classification 
• Bioresearch Monitoring 
• FDA eSubmitter 
• CDRH Learn