Sizing up BIO’s priorities and accelerated approval concerns

BIO’s push for FDA to be more flexible on accelerated approval requirements is unlikely to resonate at the agency, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin explains why BIO is concerned about the “erosion” of accelerated approval as FDA considers whether requiring confirmatory trials to be under way at the time of approval should be the default policy. He then details the trade group’s other top priorities: implementation of the Inflation Reduction Act, capital formation, and diversity, equity and inclusion issues.

BioCentury’s editors also discuss how imminent climate disclosure rules from the SEC could affect biotechs and recent trends in venture financing.

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