[ 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...[ Price : $8.95]
FDA warns Clifton, NJ-based Physitemp Instruments about Quality System, Medical Device Reporting, Unapproved Device, and Unique De...[ Price : $8.95]
A Courthouse New Service report outlines the competing arguments made before a three-judge appeals court panel in a case involving...[ Price : $8.95]
FDA commissioner Marty Makary says the agency is prioritizing efforts to accelerate drug development timelines beginning at the IN...