Non-approval in the sunlight: FDA’s CRL disclosures, the limits of confidentiality, and lessons from the EMA

Gabriela Lenarczyk, Timo Minssen, Aaron S Kesselheim

Open source

DOI: 10.1093/jlb/lsag023
Published: 2026-07
Container: Journal of Law and the Biosciences
Publisher: Oxford University Press (OUP)
Open access: unknown

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Cite this work

BibTeX

@article{allodium:10.1093/jlb/lsag023,
  title = {Non-approval in the sunlight: FDA’s CRL disclosures, the limits of confidentiality, and lessons from the EMA},
  author = {Gabriela Lenarczyk and Timo Minssen and Aaron S Kesselheim},
  year = {2026},
  journal = {Journal of Law and the Biosciences},
  doi = {10.1093/jlb/lsag023},
  url = {https://doi.org/10.1093/jlb/lsag023}
}

RIS

TY  - JOUR
TI  - Non-approval in the sunlight: FDA’s CRL disclosures, the limits of confidentiality, and lessons from the EMA
AU  - Gabriela Lenarczyk
AU  - Timo Minssen
AU  - Aaron S Kesselheim
PY  - 2026
JO  - Journal of Law and the Biosciences
DO  - 10.1093/jlb/lsag023
UR  - https://doi.org/10.1093/jlb/lsag023
ER  -

APA

Lenarczyk, G., Minssen, T., & Kesselheim, A. S. (2026). Non-approval in the sunlight: FDA’s CRL disclosures, the limits of confidentiality, and lessons from the EMA. Journal of Law and the Biosciences. https://doi.org/10.1093/jlb/lsag023

Source records

crossref · retrieved 2026-11-10T00:23:46.092Z