News

Search:
 Search

Latest News | 6 August 2012

Blaming FDA's Enforcement Discretion, Company Files for Bankruptcy

0 Likes

Missouri-based KV Pharmaceutical, the manufacturer of pre-term birth prevention compound Makena (hydroprogesterone caproate injection), has filed for bankruptcy in federal court citing the US Food and Read More...


Latest News | 26 July 2012

FDA: Challenge to Enforcement Discretion Without Standing, Merit

0 Likes

Are the US Food and Drug Administration's (FDA) discretionary enforcement actions beyond industry reproach? In a recent court filing, lawyers for the US regulators argue they are, especially as Read More...


Latest News | 6 July 2012

Pharmaceutical Manufacturer Sues FDA Over Use of Enforcement Discretion

0 Likes

Minneapolis-based K-V Pharmaceutical has a problem: its flagship product, Makena, isn’t maturing into the cash-generating product the company hoped it would become, leaving the company to face likely Read More...


RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

New Regulatory Focus Apps for iPad and iPhone