Freedom of Information Act Access to an Investigational New Drug Application.
Journal
ACS pharmacology & translational science
ISSN: 2575-9108
Titre abrégé: ACS Pharmacol Transl Sci
Pays: United States
ID NLM: 101721411
Informations de publication
Date de publication:
13 Dec 2019
13 Dec 2019
Historique:
received:
20
07
2019
entrez:
8
4
2020
pubmed:
8
4
2020
medline:
8
4
2020
Statut:
epublish
Résumé
We report our experience working with the US Food and Drug Administration (FDA) to obtain access to an abandoned investigational new drug (IND) application and subsequent application documents submitted by Hoffman-La Roche, Inc. to the agency. Contrary to others' experience and in response to our specific request, FDA provided the IND application number and 464 pages of relevant material, including the initial pharmacology review by the agency and an annual report consisting of an investigational drug brochure, clinical study protocol and amendments and detailing clinical experience with drug treatment. It may be possible to bring application files of additional drugs previously submitted to the agency into the public record to help bolster repurposing efforts and realize our shared public interest in benefiting from previous human clinical studies.
Identifiants
pubmed: 32259081
doi: 10.1021/acsptsci.9b00056
pmc: PMC7089016
doi:
Types de publication
Editorial
Langues
eng
Pagination
497-500Informations de copyright
Copyright © 2019 U.S. Government.
Déclaration de conflit d'intérêts
The author declares no competing financial interest.
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