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Last updated about 7 hours ago
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
about 7 hours ago
The following are the medical, statistical, and clinical pharmacology reviews of pediatric...
FDA approves drug for type of abnormally fast heart rhythm
about 9 hours ago
The U.S. Food and Drug Administration (FDA) has approved Cardamyst (etripamil) nasal...
FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer
about 11 hours ago
On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki...
Study of Sex Differences in the Clinical Evaluation of Medical Products
about 13 hours ago
This guidance provides recommendations for increasing enrollment of females in clinical trials...
Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs
about 13 hours ago
This guidance recommends approaches that sponsors of clinical trials intended to support...
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
about 14 hours ago
This guidance recommends approaches that sponsors of clinical trials intended to support...
Environmental Impact Review at CDER
about 14 hours ago
OPS Environmental Impact Review at CDER: ENVIRONMENTAL IMPACT: CLAIMS FOR CATEGORICAL EXCLUSION
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
about 15 hours ago
Drug Safety
Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
about 16 hours ago
Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and...
Examples of Accepted Emerging Technologies
3 days ago
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote...
How to Participate in Emerging Technology Program (ETP)
3 days ago
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote...