[ 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]
FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/...[ Price : $8.95]
Two bipartisan senators press FDA to take a more proactive role in policing prescription drug advertising, citing a surge in misle...[ Price : $8.95]
Ultragenyx Pharmaceutical refiles a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilip...[ 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...