Market Forces May Impact GDUFA III Talks
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.
You may also be interested in...
Association for Accessible Medicines' Davis tries to counter concerns that the long-stalled measure would incentivize lawsuits against brand companies; witnesses at a House subcommittee hearing on drug pricing legislation also testified that the BLOCKING Act would create an overly broad and complicated framework for triggering 180-day exclusivity.
US FDA would get an overall increase in funding under the president's fiscal year 2020 budget proposal, although the generic drug industry opposes reforms targeting the 180-day exclusivity clock for first filers.
New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to attach suffixes to future approvals.