[ Price : $8.95]
In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlines an expansive agenda to accelerate drug appro...[ Price : $8.95]
FDA grants full approval for Kites CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or ref...[ Price : $8.95]
CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file deci...[ Price : $8.95]
CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device regulatory activities.[ Price : $8.95]
FDA says it will exercise enforcement discretion and not enforce specific sections of the Federal Food, Drug, and Cosmetic Act as ...[ Price : $8.95]
President Trump prepares to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agree...[ Price : $8.95]
A rare disease coalition calls on the Trump administration to appoint a new CBER director who understands rare disease drug develo...[ Price : $8.95]
An FDA untitled letter cautions the Fort Myers, FL-based LeeSar drug outsourcing facility about CGMP and other violations in its p...