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

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 have received a refuse-to-file (RTF) letter, almost never disclose the contents of such letters, and never make their full text public. It stated that the most common reason for issuing an RTF is missing information required to assess product quality, safety or efficacy – information that is of critical interest to patients, potentially useful to companies developing drugs for the same condition or using similar technologies, and indisputably valuable for investors. ...