Multiple stakeholders call for CBER to receive more prescription drug user fee funds amid growing cell and gene therapy popularity.
The bright lights of the prescription drug user fee program may be ready to shift more toward the US Food and Drug Administration’s biologics center.
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FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.
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.
