Multiple congressional offices attended a briefing on GDUFA III with FDA and industry officials, suggesting plans for the must-pass bill already are in the works.
Negotiations to reauthorize the generic drug user fee program have not been completed, but Capitol Hill already is interested in the final product.
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Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.
Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.
Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.
