pt9b00056_si_001.pdf (152.68 MB)
Freedom of Information Act Access to an Investigational New Drug Application
journal contribution
posted on 2019-08-19, 21:17 authored by Noel T. SouthallWe
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.