Politics, Policy & Law

Study could revive pressure for FDA to release refuse-to-file, complete response letters

Regulatory information that could benefit patients, drug developers is rarely disclosed, FDA officials say

Regulatory information that could benefit patients, drug developers is rarely disclosed, FDA officials say.

A study conducted by FDA staff could revive stalled decades-long attempts to allow the agency to routinely disclose the reasons why it refuses to accept applications for new drugs and biologics or declines to approve them. 

The study showed that companies rarely reveal that they