Recent FDA Law Blog Entries from www.fdalawblog.net

DC District Court Denies Sanofi Summary Judgment Motion in Generic ELOXATIN Case; Refuses to Reinstate 30-Month Stay on ANDA Approvals

Qualified Health Claims: The Commercial Speech Battle Continues

FDA Plans to Regulate Laboratory Developed Tests; Many Questions Remain as to Details of Regulatory Scheme

The Other Shoe Drops . . . . Sanofi Sues FDA Over Generic LOVENOX Approval

Articles and Presentations

The Problem of Regulatory Uncertainty  July 2010

Whistleblowers: Treat Them With Kid Gloves  July 2010

Regulatory Pathways for Clearance or Approval of IVDs  May 2010

The Lanham Act: Another Vehicle to Enforce the Food, Drug, and Cosmetic Act?  April 2010

Oversight of Research Use Only Products  March 1, 2010

more articles...