Litigation
News This Week
PMTA
Regulation
U.S. FDA
Second Chance: MDO Legal Win Presents Opportunity
How companies can make the most of a recent ruling requiring FDA to reassess 1,000s of PMTA rejection notices.Read More
Gripum claims the MDO was unfairly issued because Congress and FDA had no “ascertainable standards."Read More
The update requires no additional action by companies with pending grandfather determination request.Read More
Litigation
News This Week
PMTA
Regulation
U.S. FDA
Vapor Makers Prevail Over FDA in PMTA Denial Suit
The FDA’s refusal to review marketing plans was error and not harmless (disagreeing with Fifth and DC Circuits).Read More
These studies provide critical information during the review of product applications. Read More
An industry perspective of the external CTP Reagan-Udall analysis suggests areas of focus for reviewers.Read More
Despite onerous requirements on applicants, the agency was happy to cut its own paperwork, writes Filter.Read More
The court ruled FDA acted within Congress' authorization, and decisions were supported by evidence. Read More
The court denied the stay mainly because Fontem waited too long to file the emergency motion.Read More
The limited product debut in the UK has received overwhelming recognition from users and commercial partners.Read More
