Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...

FDA’s LDT final rule published in May 2024 amends FDA’s regulations to make explicit that IVDs will be regulated as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA), including when the ...

“Regulatory flexibility must be tailored for cell and gene therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “These are common-sense reforms that will address the unique characteristics of ...

A key element of the law is the establishment of a system to trace food, which is key to reducing the severity of foodborne ...

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

Please provide your email address to receive an email when new articles are posted on . Two FDA committees overwhelmingly voted to strike down monitoring requirements under a Risk Evaluation and ...

The U.S. Food and Drug Administration (FDA) has still not fully implemented the foodborne illness provisions of the Food ...

FDA officials told GAO that competing priorities and an agency reorganization in late 2024 have slowed progress, estimating ...