In Re: FDA Guidance to Industry on Financial Disclosure of Clinical Investigators
- Case Date: 7/25/2011
- Project Name: Health Care Project
On July 25, 2011, WLF filed comments with the Food and Drug Administration urging the agency to revise its proposed new Guidance to industry on financial disclosure of clinical investigators. The proposed guidance lacks clarity in explaining how FDA uses financial information disclosed to FDA at the marketing application stage of a new drug or device. WLF praised FDA for not adopting an OIG recommendation that financial information be disclosed at the pretrial application stage, but urged FDA to provide better transparency in its Guidance as to how the information is evaluated. Additionally, WLF urged FDA to err on the side of caution when adopting any policy relating to public disclosure of financial information.
|Awaiting FDA action.|
More Information and Downloads:
7/25/2011: Download the Comments