BioCentury
ARTICLE | Regulation

HHS imposes new review timeline report policy on FDA

January 12, 2021 1:19 AM UTC

HHS Monday announced that it will require FDA to collect and report data about the length of new drug reviews using metrics that are different, and far more stringent, than those the agency has traditionally used.

In addition, HHS stated that some waivers of premarket notification requirements for medical devices that FDA granted on a temporary basis in response to the COVID-19 emergency will be made permanent, and it is seeking comments on a proposal to make additional waivers permanent. ...