This bill requires the Food and Drug Administration (FDA) to continue to review applications for certain biological products under an earlier review process, notwithstanding recent FDA guidance. (A 2009 law established a new procedure for approving biological products but allowed certain products in an already approved product class to receive approval under the earlier procedure until March 23, 2020; subsequently, in December 2018, the FDA issued guidance stating that an application filed under the earlier procedure that is not approved by March, 23, 2020, will not be approved.)
The bill requires the FDA to continue reviewing an application filed not later than March 23, 2019, under the earlier procedure, even if it was not approved as of March 23, 2020.
Such an application not approved after October 1, 2022, shall be deemed withdrawn.
Such an approved application shall be deemed a biological product license.