On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more
On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
1/17/2025
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Compliance ,
Disclosure Requirements ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
New Guidance ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements