• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (updated)
• CDER Organization Charts [HTML] [PDF] (updated)
• Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated)
• Genentech informs healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML). MedWatch Safety Information

September 11, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)

September 9, 2008

• Cyber Letters for Years: 2005, 2006, 2007 (updated)
• Guidance for Industry: Concept Papers
  • Animal Models — Essential Elements to Address Efficacy Under the Animal Rule [PDF]
  • PDUFA Pilot Project: Proprietary Name Review [PDF]
• New and Generic Drug Approvals
  • Monistat 3 (miconazole nitrate) Vaginal Cream, Johnson and Johnson Healthcare Products, Manufacturing Change or Addition
  • Photofrin (porfimer sodium) Injection, Axcan Pharma US, Inc., Efficacy Supplement with Clinical Data to Support

September 8, 2008

• Warning Letter: Bystolic (nebivolol) Tablets

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September 12, 2008 Federal Register: Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket   September 11, 2008 Federal Register: Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of Comment Period Summary Information for: COBAS TaqMan HBV Test For Use With the High Pure System FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008 (Final Agenda Now Available) Federal Register: General and Plastic Surgery Devices: Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period Class I Medical Device Recall: Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs) Federal Register: Public Advisory Panels or Committees: Request for Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives    September 9, 2008 Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 020   September 8, 2008 Federal Register: FDA Clinical Trial Requirements Regulations, Compliance, and Good Clinical Practice Conference; Public Workshop   News & Events • Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product • Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Public Health Notifications: • Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning • Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Class I Medical Device Recalls - • Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank • Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System • Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board) FDA Patient

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