FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics

Center for Biosimilars

9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress as keynote speaker of the Association for Accessible Medicines’ GRx+Biosims annual conference this week.

She addressed the HHS recommendations for pricing reforms in the drug industry, noting that many patients are not adhering to their medications because of high prices, and also said that, now that COVID-19 pandemic is more under control, the FDA is returning to business as usual, addressing applications for biosimilar and generic approvals and conducting domestic factory inspections, at least, in a normal fashion.

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Michael Wonder

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Michael Wonder