Latest FDA News

Radioactive Drug Research Committee (RDRC) Program

Regulating the use of radioactive drugs in basic research

Providing Over-the-Counter Monograph Submissions in Electronic Format

Providing Over-the-Counter Monograph Submissions in Electronic Format

GDUFA III Drug Master File (DMF) Review Enhancements

Effective communication among ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals.

GDUFA II Drug Master Files (DMFs)

Info helps to master FDA’s list of Drug Master Files (DMFs) and info on submission of DMFs to agency. FDA provides info on DMF list, status of DMF, types of DMF, and more.

FDA updates on hand sanitizers consumers should not use

FDA Warns consumers and healthcare professionals of Hand Sanitizers contaminated with Methanol
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