May 5, 2022
Life Sciences
  • The House Energy and Commerce Committee released a user fee authorization bill that would allow regulators to revoke approval for drugs cleared through the accelerated approval program if drugmakers delay their required follow-up trials. A stronger measure from an earlier draft bill appears to have been taken out, though, and it includes some industry-friendly revisions, such as allowing drugmakers to use real-world evidence to support their follow-up studies. (Article here)