ORLANDO, Fla. – US FDA Deputy Commissioner for Policy, Planning, Legislation and Analysis Anna Abram told the Association for Accessible Medicines' annual meeting here that they should stop worrying and love the Trump administration's proposed reforms to 180-day generic exclusivity.
Included as part of the administration's budget proposal, the concept would start the 180-day exclusivity clock if the first filer hasn't been approved but another ANDA gets tentative approval
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