FDA releases a discussion paper entitled 22 Case Studies Where Phase 2 and Phase 3 Trials Had Divergent Results to illustrate the challenges drug deve...
An HHS annual fraud and abuse control program report says FDA opened 31 Prescription Fraud Program criminal probes in FY 2016.
Outgoing FDA commissioner Robert Califf announces creation of an Oncology Center of Excellence directed by Richard Pazdur.
Federal Register Notice: FDA makes available a draft guidance for Drug and Device Manufacturer Communications With Payors, Formulary Committees, and S...
Federal Register Notice: FDA makes available a draft guidance on Medical Product Communications That Are Consistent With the FDA-Required Labeling Qu...
Federal Register Notice: FDA cancels a 2/16-planned Psychopharmacologic Drugs Advisory Committee meeting that as announced in the 12/27/2016 Federal R...
Federal Register Notice: FDA reopens the comment period and releases a new memorandum concerning its comprehensive review of regulations and policies ...
FDA obtains a permanent injunction against a California dietary supplement manufacturer requiring it to cease operations for violating the FFDCA.