• The Adverse Event Reporting System (AERS) Latest Quarterly Data Files (updated)
• Creating New Knowledge: FDA & Industry in Dialogue, May 6, 2008, Philadelphia, PA.  The seventh conference between the FDA and industry sponsored by Temple University School of Pharmacy.  Keynote Speaker: Janet Woodcock, M.D., Director, CDER.  This conference provides participants, industry, and the FDA a forum for dialogue about critical issues affecting drug development. Agenda and registration
• New and Generic Drug Approvals
  • Children’s Cetirizine Hydrochloride Sryup, Perrigo, Approval
  • Fiorinal with Codeine (butalbital, aspirin, caffeine, codeine phosphate) Capsules, Watson Labs, Labeling Revision
  • Lamivudine Tablets, Ranbaxy, Tentative Approval
  • Levalbuterol Hydrochloride Inhalation Solution, Breath Ltd., Approval
  • Oxcarbazepine Tablets, Apotex, Approval
  • Theophylline and Dextrose in Plastic Container, B Braun Medical, Labeling Revision

April 10, 2008

• Bioresearch Monitoring Information System (BMIS) (updated)
• Cyber Letters (updated)
• FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic.
• New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated)
• Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated)
• Pfizer informs healthcare professionals and patients of updated safety information in the labeling for Exubera, a short-acting insulin. MedWatch Safety Information
• Schwarz Pharma recalls Neupro, a transdermal delivery system used to treat early stage Parkinson’s disease, at the end of April. MedWatch Safety Information

April 9, 2008

• BPCA/Pediatric Exclusivity Statistics:
  • Breakdown of Requested Studies Report (updated)
  • Spectrum of Diseases/Conditions (updated)
  • Written Requests Issued (updated)
  • Written Requests Statistics (updated)
  • Pediatric Exclusivity Granted (updated)
• Cubist Pharmaceuticals, Inc. informs healthcare professionals that a potentially significant impurity has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MedWatch Safety Information
• Dissolution Methods Database (updated)
• Drugs@FDA Downloadable Data Files (updated)
• Research in the Division of Drug Marketing, Advertising, and Communications (DDMAC)

April 8, 2008

• Drug Shortages
  • Current Drug Shortage: Neupro (rotigotine transdermal system)
  • Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg
• FDA releases information on adverse events and heparin
• Guidance for Industry: Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document [PDF]
• Impurity Evaluation of Heparin Sodium by ¹H-NMR Spectroscopy (updated)
• Manuals of Policies and Procedures (MaPPs)
  • 4631.3R Budget Execution Planning and Reporting/Program Management System Reports
  • 4641.5 Authority to Reimburse Employees for Business Calls Made on Personal Car Phones
  • 7700.1 Management of the Regulatory Science and Review Enhancement Committee
• New and Generic Drug Approvals
  • AUGMENTIN (amoxicillin, clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
  • Cetrotide (cetrorelix) Injection, EMD Serono, Labeling Revision
  • Emtriva (emtricitabine) Capsules, Gilead Sciences, Labeling Revision
  • Emtriva (emtricitabine) Oral Solution, Gilead Sciences, Labeling Revision
  • Hydrochlorothiazide Tablets, Apotex Corp., Facility Addition
  • Navane (thiothixene) Capsules, Pfizer Inc., Labeling Revision
  • Terbinafine Hydrochloride Tablets, Aurobindo Pharma, Control Supplement

April 7, 2008

• Guidance Document: International Conference on Harmonisation; Guidance on E15 Pharmacogenomics Definitions and Sample Coding [PDF]

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April 11, 2008 Consumer Information on: CONTAK RENEWAL 3 AVT Models M150, M155, M157 and M159 - P010012S037   April 10, 2008 Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, Form FDA 3602A. FDA & YOU - News for Health Educators and Students - Spring 2008 Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Waivers for Conflicts of Interest Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 17, 2007 - Minutes Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Minutes   April 7, 2008 510(k) Final Decisions - March 2008

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