Experts propose suggestions to improve transparency of FDA complete response letters

Beskrivelse

Regulatory Focus interviewed me about my co-authored research published in the Journal of Law and the Biosciences. The discussion examines how timely publication, clearer redaction standards, neutral summaries, structured metadata, and retrospective disclosure of FDA complete response letters could support regulatory learning while protecting genuinely confidential commercial information. It also considers lessons from the European Medicines Agency’s approach to regulatory transparency.