The U.S. Food and Drug Administration issued a direct final rule on September 21, 2026 that updates its regulations to ...

Please provide your email address to receive an email when new articles are posted on . The guidelines address issues related to development and prescription of non-opioid pain drugs. They are part of ...

The medtech industry is awaiting FDA guidance on generative AI. The agency has sought feedback in advisory meetings and a ...

On July 13, 2026, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its guidance on “Psychedelic Drugs: Considerations for Clinical Investigations,” replacing the June 2023 draft ...

Because fresh-cut produce doesn’t undergo a final step to eliminate harmful pathogens, the agency’s recommendations emphasize preventing contamination throughout the production process.

Please provide your email address to receive an email when new articles are posted on . The FDA frequently identifies uncertainties about newly approved cancer drugs, but they are often omitted in ...

The Trump administration is preparing to roll out new dietary guidelines for Americans in early January, a move Food and Drug Administration (FDA) officials say will kick off a broader food policy ...

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.

FDA finalizes guidance on assessing bioequivalence of topical drugs The US Food and Drug Administration (FDA) has finalized guidance for manufacturers on using physicochemical and structural (Q3) ...

The FDA is moving toward defining allergen thresholds, providing science-based guidance on when unintended allergen exposure is unlikely to cause reactions in most allergic consumers and clarifying ...