The U.S. Food and Drug Administration should make more information public, including its reasons for refusing to approve a drug or device, an agency task force recommended on Wednesday.
If adopted, the changes would shed considerable light on a review process that affects the entire drug and device industries. All of the proposals would offer the public more details on key agency decisions.
Wider disclosure could alter companies' ability to control news that could affect their stock prices, especially negative FDA actions such as denying a product or highlighting safety concerns.
"The FDA would make substantially more information about the regulatory process available to the public" if it accepts the proposals, FDA Deputy Commissioner Joshua Sharfstein and Afia Asamoah, director of the transparency effort, wrote in the New England Journal of Medicine.
The task force included the FDA's top lawyer, chief scientist and the heads of the FDA's drug, device and other centers.
Among the FDA Transparency Task Force's recommendations was that the agency disclose letters to companies explaining why it declined to approve a drug or device or refused to accept an application.
Such letters, known as "complete response" or "not approvable" and refuse-to-file letters, are currently only released if and when a company decides to make them public.
The North Dakota supreme court revived the state’s abortion ban on Friday, once again making it...
Cases of infant botulism tied to the ByHeart infant formula recall have nearly tripled across 15...
A federal judge officially approved drug maker Purdue Pharma’s latest deal to settle thousands of lawsuits...
