The regulator cited inconsistencies with how safety trial data was recorded in a report released ahead of the advisory committee’s meeting on Wednesday.
Study shows Merck’s Januvia does not increase heart risks; a former Genentech exec launches a behavioral health business; lawmakers want black-box warnings on more opioids
In sunny world of LASIK marketers, a dark underbelly
Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.
Novartis apologizes for slow reporting
July 31, 2014
5:44 pm
Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.
Novartis says it buried studies
June 16, 2014
5:06 pm
The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.
FDA seeks EMR data-mining partner
January 6, 2014
6:50 pm
The regulator’s proposed database could help identify adverse events.