March 15, 2004

• 7346.832, Pre-Approval Inspections/Investigations (updated)

• New and Generic Drug Approvals
  • Thyrogen (thyrotropin alfa) Injection, Genzyme Corporation
  • ULTRAVIST (brand of iopromide) Injection, Berlex Laboratories, Inc.
  • Quinapril Hydrochloride Tablets, Ranbaxy Pharmaceuticals, Tentative Approval
• Pediatric Drug Development:
  • Pediatric Exclusivity Granted (updated)

March 12, 2004

• FDA/NIH Joint Symposium on Diabetes: Targeting Safe and Effective Prevention and Treatment, May 13-14, 2004, Bethesda, MD.  Tentative Advisory Committee Meetings, CDER (updated)

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