Generics Firms Race To Withdraw ANDAs
Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.
You may also be interested in...
Senate Drug Pricing Legislation Clears Committee With Generic Exclusivity “Parking” Provision Unchanged
US Senate health committee advanced the Lower Health Care Costs Act with few pharma-related changes. Bill’s drug pricing provisions include the CREATES Act and a requirement that manufacturers report to HHS on price increases.
While FDA is on pace to again break its record for full ANDA approvals in FY 2019, the first-cycle approval rate is dropping, as illustrated in our charts.
AAM's Chip Davis said a user fee cut is not in order, but industry consolidation and product launch problems may mean it cannot accept another large increase.