FDA clears a Treace Medical Concepts 510(k) to expand indications of the Lapiplasty 3D Bunion Correction System to treat pediatric patients 12 years o...
CDER director Janet Woodcock says the Center has six active initiatives ongoing as part of its new drugs regulatory program modernization.
Hi-Tech Pharmaceuticals sues FDA claiming that it bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force comp...
A federal jury in Boston convicts Insys Therapeuticss founder and four former executives on charges they bribed health professionals to prescribe Subs...
Five stakeholders give FDA technical comments on a draft guidance on food effects on drugs.
Researchers say U.S. trade agreement containing protections sought by drug companies dont always provide benefits to Americans promised as part of the...
FDA posts a summary of changes to 17 REMS made in March and April.
Reuters reports the Justice Department is intervening in two whistleblower suits alleging that Questcor Pharmaceuticals illegally promoted its Acthar ...