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BIO - USITC Investigation - COVID-19 TRIPS Waiver - Post hearing Supplementary Submission

May 5, 2023

In this Post-hearing Supplementary Written Submission, BIO submits detailed comments to support the USITC investigation into the proposed WTO IP Waiver for COVID-19 therapeutics.

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BIO - USITC Investigation - COVID-19 TRIPS Waiver - Posthearing Supplementary Submission
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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
BIO joined with more than 40 groups in calling on Congress to set 2024 funding for the U.S. Codex Office at or above the 2023 level. 
BIO’s comments support accelerated approval as an important regulatory pathway that allows patients with serious and life-threatening illnesses such as cancer to have earlier access to promising therapies.