Pink Sheet Podcast: US FDA’s Coronavirus-mandated Virtual Advisory Committees, Proventil HFA First Generic, Zofran Liability Suit
Pink Sheet reporters and editor discuss how the US FDA was pulled into a product liability suit for GSK’s Zofran and the approval of Cipla’s first generic of an albuterol sulfate metered dose inhaler, as well as the agency’s plans for virtual advisory committee meetings.
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First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
To help with the transition to Biden’s COVID-19 response, Woodcock will retain some therapeutic development duties in the program the Trump administration had called Operation Warp Speed.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.