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Radioactive Drug Research Committee (RDRC) Program
by FDA on October 6, 2022 at 9:49 pm
Regulating the use of radioactive drugs in basic research
Providing Over-the-Counter Monograph Submissions in Electronic Format
by FDA on October 6, 2022 at 8:52 pm
Providing Over-the-Counter Monograph Submissions in Electronic Format
GDUFA III Drug Master File (DMF) Review Enhancements
by FDA on October 6, 2022 at 8:35 pm
Effective communication among ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals.