Some Generics May Get To Skip Fed Study Requirement If US FDA Research Pans Out
Office of Generic Drugs official says the FDA may be able to harmonize its requirements with regulators who do not have a blanket mandate.
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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.
ANDA sponsors fret price erosion – and potential changes to 180-day exclusivity.
US agency has received 'very few' inquiries about the drugs on the list since its release.