Pink Sheet Podcast: Aduhelm Label Change, First Half Drug Approvals, FTC Investigative Power
Pink Sheet reporters and editors discuss the implications of Aduhelm’s updated indication, CDER’s new drug approvals in the first half of 2021, and an FTC policy change that will make investigating pharma easier.
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US FDA veterans offered varying opinions as to the benefits and risks of the CBER director taking on a more hands-on role in reviewing Pfizer’s COVID-19 vaccine. The move was called unusual, but not inappropriate; some said it should be monitored closely to ensure review staff’s judgements are not pushed aside.
ARPA-H could be a solution to some of FDA’s long-running complaints about US clinical trial infrastructure, the agency's cancer chief says.
Sandra Retzky worked at AstraZeneca and in Delaware's Medicaid fraud unit before joining the US FDA in 2016.