Reopening Hatch-Waxman Is Decision For Congress, Not FDA, CDER’s Woodcock Says
Responding to a lawmaker’s question on whether the incentives in Hatch-Waxman strike the appropriate balance, Center for Drug Evaluation and Research Director Janet Woodcock says the issue “is beyond my purview.”
You may also be interested in...
After five months on the job, Generic Pharmaceutical Association President and CEO Ralph Neas is optimistic about the industry’s future but prepared to do battle against any efforts to re-work the landmark 1984 law. Preparations include establishing a new non-profit arm, the Affordable Medicine Research Institute, which will focus on research and public education about generics and biosimilars.
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.