┌──────────────────────────────────────────────────────────────┐ RECORD TYPE ......... SUBJECT FILE SUBJECT TYPE ........ ORG FILE OPENED ......... 2026-07-06 00:16 UTC APPEARANCES ......... 2 ANNOTATIONS KNOWN ALIASES ....... 2 └──────────────────────────────────────────────────────────────┘
U.S. Food and Drug Administration (FDA)
ALSO APPEARS AS
- FDA
- U.S. Food and Drug Administration (FDA)
APPEARS IN THE MARGINS OF
- Study 329: FDA and International Regulatory Investigations into Adverse Event Reporting
Study 329, a clinical trial for the antidepressant paroxetine (Paxil/Seroxat) in adolescents, has been the subject of allegations regarding selective reporting of adverse events. Concerns primarily ce…
- Study 329: IRB Approval Process and Conflicts of Interest Review
This dossier investigates the Institutional Review Board (IRB) approval process for Study 329, a controversial clinical trial on paroxetine in adolescents. IRBs are committees federally required to re…