The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...

WASHINGTON -- The US Food and Drug Administration said Wednesday it will be lowering its targets for sodium content in processed, packaged, and prepared foods, but not to levels recommended for ...

The U.S. Food and Drug Administration (FDA) issued new draft guidance on Sept. 20, 2025, surrounding expedited programs for regenerative medicine therapies for serious conditions. The draft guidance ...

The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step. Instead, advances in ...

Recent advances in autoimmune disease treatment include striking CAR-T cell therapy results, novel immune-targeting drugs, and new FDA regulatory initiatives for rare conditions. Early trials show ...

When a patient in an early-phase drug trial experiences a serious side effect today, weeks or even months can pass before ...

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...

The FDA has quietly proposed legislation that would give it more authority to deem drugs misbranded in pharma DTC ads. But ...

Twelve months after releasing a roadmap to shift away from animal testing requirements, the FDA has declared mission ...

Qualifying for *** COVID-19 vaccine really depends on your age, health, and insurance coverage. And now most people don't meet the guidelines. On Wednesday, the Food and Drug Administration approved ...

The Food and Drug Administration today announced it is accelerating regulatory action on a new class of psychedelic-based therapies, following an April 18 executive order calling to speed up access to ...

The FDA has taken a significant step in advancing implementation of real-time clinical trials (RTCT).