[ Price : $8.95]
FDA solicits comment on a draft guidance to assist drug sponsors and medical device manufacturers who want to coordinate developme...[ Price : $8.95]
FDA issues a guidance on reporting formats for medical device computational modeling and simulation studies.[ Price : $8.95]
Alcon calls on FDA to eliminate the in vitro option for bioequivalence testing for generic Durezol.[ Price : $8.95]
Alcon asks FDA to revise its Ciprodex product-specific guidance to eliminate any in vitro option to demonstrate bioequivalence.[ Price : $8.95]
A Tufts Center for the Study of Drug Development analysis says that FDA review time for diabetes drugs has increased in recent yea...[ Price : $8.95]
CDRH publishes 10 regulatory science priorities that will be its focus in FY 2017.[ Price : $8.95]
Reed Smith attorney James Beck reviews cases that explore the legal issues in proving causation in state-law product liability ina...[ Price : $8.95]
Hogan Lovells attorneys say that a CDER briefing document raises a concern that data from a Chantix post-marketing study were comp...