Sep 13 2018

The US Food and Drug Administration is considering a proposal that would make it easier for members of the public to obtain information via Freedom of Information Act (FOIA) requests.

Under this proposed new rule, when the FDA receives three or more FOIA requests for a particular record, the record then would be made public automatically.

In addition, the proposed new rule would instruct FDA officials to create a formal procedure to proactively identify and post records of general public interest. The FDA already has dedicated web pages for Frequently Requested or Proactively Posted Compliance Records and Frequently Requested or Proactively Posted Drug-Specific and Other Records.

According to the text of the proposed rule, these new measures “will update the regulations to reflect changes to the organization, to make the FOIA process easier for the public to navigate, and to make certain provisions clearer. Taken together, these changes will enhance transparency for the public with regard to FDA activities.”

The FDA is accepting comments on the proposed rule until Nov. 13. Click here to read the full text of the proposal.

Also, click here to read more about the FDA’s proposed FOIA changes in Regulatory Focus. 

For regulatory consultation of your FDA-regulated product, contact Dr. Heather Hatcher, Regulatory Scientist in Womble Bond Dickinson’s Winton-Salem office.

Heather Hatcher, Ph.D., is a regulatory scientist on Womble Bond Dickinson’s Life Sciences and Pharmaceuticals Sector Team. Drawing on her background as a research scientist, Hatcher guides clients through FDA regulatory strategies and product development issues for drugs, biologics and medical devices. Her experience includes the preparation of pre-submissions, initial Investigational New Drug (IND) and Investigation Device Exemptions (IDE) applications, annual progress reports, and FDA meeting requests.

#FDA #compliance #FOIA