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Main Subject: Health

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.)

HR19-116, S1895-116, S2103-116,

House floor actions Actions

IntroReferral
Mar. 09 2020	Referred to the House Committee on Energy and Commerce.

Library of Congress Actions

IntroReferral
Mar. 09 2020	Introduced in House Introduced in House

House bill HR6155-116

To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes.

House bill HR6155-116

To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products, and for other purposes.

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