US FDA Sets Generic Approval Record, But Generic Sponsors Aren't Celebrating
FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition.
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Biopharma will continue to seek ways to pass legislation reducing the 70% discount in Medicare Part D coverage gap but it looks like industry's next chance will be after the November elections.
Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.
OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.