FDA wants to reverse the deline in NDA approvals; the agency may have a key ally at a new center in Arizona.
By Cole Werble
The critical path for FDA’s effort to improve the drug development processruns through Tucson, Arizona.
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With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
