Reopening Hatch-Waxman Is Decision For Congress, Not FDA, CDER’s Woodcock Says
Executive Summary
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...
GPhA’s Neas Preaches Vigilance Against Reopening Hatch-Waxman Act
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.
Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA
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.
2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: