The Prescription Drug User Fee Act (PDUFA) of 1992 was enacted to augment the resources of the Food and Drug Administration (FDA) that are devoted to reviewing applications for drugs for humans ...

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments, 86 Fed. Reg. 43553 (Aug. 9, 2021). [2] Epstein Becker Green Insight “Deconstructing ...

The Food and Drug Administration has banned the use of the dye Red No. 3 in all food and ingested drugs. Here’s what foods and drugs contain the coloring, and how it compares with Red No. 40 and ...

Data analyzed by CNN shows mifepristone — the first drug in the medication abortion process — is even safer than some common, low-risk prescription drugs, including penicillin and Viagra.

The Food and Drug Administration’s ruling earlier this week allows retailers to sell hearing aids to adults with mild to moderate hearing loss without a clinical assessment.

Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.

By Annette Choi and Will Mullery, CNN The Supreme Court on Friday protected access to a widely used abortion drug by freezing lower-court rulings that placed restrictions on its usage. A federal ...