FDA study shows few public disclosures from complete response letters

A study led by the associate commissioner of FDA's Office of Public Health Strategy and Analysis found that drug sponsors that received complete response letters often failed to disclose publicly the reasons why their applications were not approved.

Researchers led by Peter Lurie found that 21% of sponsor press releases did not contain information matching statements in the corresponding complete response letters, while no press release was issued for 18% of complete response letters. ...