USA – FDA revokes policy issued by Trump administration

The US Food and Drug Administration (FDA) on Friday revoked a policy issued in the final days of the Trump administration that was purportedly aimed at increasing transparency related to drug review timelines.
 
The policy, announced by the Department of Health and Human Services (HHS) on 15 January 2021, would have required FDA to publish “redundant” information on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the agency for review.
 
The move is the latest in a series of actions FDA and HHS have taken to walk back last-minute policies the previous administration issued on its way out. (RELATED: HHS pushes through last-minute policies impacting FDARegulatory Focus 12 January 2021; HHS hits pause on Trump era SUNSET ruleRegulatory Focus 22 March 2021; FDA walks back Trump-era premarket notification exemptionsRegulatory Focus 15 April 2021)…