Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved ...

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 ...

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

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 (FDA) released its final ruling on requirements for the “healthy” nutrient claim, more than two years after initially proposing an update. Manufacturers must ...

FDA requests information to explore whether current gluten labeling rules adequately protect consumers, with implications for ...

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 ...

CTK recently completed FDA OTC registration and related compliance steps for three white-label suncare products: a sun lotion ...

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...

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