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Market Forces May Impact GDUFA III Talks

Executive Summary

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.

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CREATES Act: Republican Lawmakers Worry About Frivolous Lawsuits By Generic Firms

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.

Trump FY 2020 Budget Renews Push To Reform 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.

Policy Reversal: FDA Will No Longer Require Suffixes For Older Biologics

New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to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.

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