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. Specifically, the bill applies to applications that were filed under the earlier process on or before March 23, 2019, and were still pending on March 23, 2020. (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.)
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 133.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S4809)
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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