Tag Archives: PDUFA

The Orphan Drug Act at 30 Years: What's Next?

30 years ago last week, the US Orphan Drug Act came into being, and with it, a door of possibilities opened up for patients with literally thousands of untreated diseases. The anniversary marks the beginning of a journey where medicines for rare diseases have gained a foothold in the portfolios of drug companies large and […]
Posted in Biotech, FDA, IP, Orphan Drugs, Regulatory, Strategy | Also tagged , , , , , | Leave a comment

Congress Move Promptly to Finalize FDA User Fees

Legislation fails to establish a national track-and-trace system, but tackles shortages, orphans. House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support Food and Drug Administration regulatory programs. The bipartisan measure moved through Congress quickly with an eye to avoid getting tangled up in fallout from […]
Posted in FDA, Regulatory | Also tagged , , | Leave a comment

Unmet Need in the Migraine Space?

Allergan CEO David Pyott is bullish on Botox’s potential as a salve for chronic migraine. He’s also betting on a next-gen dihydroergotamine (DHE) – Levadex – from MAP Pharmaceuticals.
Posted in FDA, Global, Marketing, Regulatory, Strategy, Technology | Also tagged , , , | 2 Comments
  • Categories

  • Meta