Freedom of Information Act Access to an Investigational New Drug Application

This article not subject to U.S. Copyright. Published 2019 by the American Chemical Society. Noel T. Southall Abstract 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 […] Source