In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlines an expansive agenda to accelerate drug approvals, lower costs, a...
FDA grants full approval for Kites CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell ...
CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file decision.
CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device regulatory activities.
FDA says it will exercise enforcement discretion and not enforce specific sections of the Federal Food, Drug, and Cosmetic Act as they apply to hemp-d...
President Trump prepares to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agreed to participate in ...
A rare disease coalition calls on the Trump administration to appoint a new CBER director who understands rare disease drug development and values the...
An FDA untitled letter cautions the Fort Myers, FL-based LeeSar drug outsourcing facility about CGMP and other violations in its production of compoun...
