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...
FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/or diagnosis devices...
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...
FDA warns Clifton, NJ-based Physitemp Instruments about Quality System, Medical Device Reporting, Unapproved Device, and Unique Device Identifier viol...
A Courthouse New Service report outlines the competing arguments made before a three-judge appeals court panel in a case involving FDAs decision to re...
