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

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 ...

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

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...

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 ...

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 ...

How the industry can break the larger goal of full supply chain traceability into manageable, achievable steps ...

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 ...

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

Please provide your email address to receive an email when new articles are posted on . The FDA plans to reduce and potentially replace animal testing for developing monoclonal antibody therapies and ...

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect public health. Here's how.