Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of ...

The Food and Drug Administration is rolling out an aggressive plan to make generative AI a linchpin in its decision-making, ...

The expansion builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program ...

A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.

The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.

Donald Trump has promised to create a pro-AI environment, but even tech companies are frustrated by federal cuts that hamper regulatory processes. Paul Webster reports.

Changes to the U.S. regulatory landscape could dampen the ability to authorize new products AND enforce existing regulations.

The Food and Drug Administration on Thursday announced an aggressive agency-wide Artificial intelligence adoption timeline ...

Recent FDA alert reveals concerning side effects of topical finasteride hair treatments that may persist long after stopping ...

The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...

Following a similar decision in case the trade group Outsourcing Facilities Association brought against FDA over its decision ...