Legislation expanding the US FDA's generic drug priority review pathway beyond sole-source drugs to generics entering markets with "limited competition" was added to the Senate's user fee reauthorization bill.
Generic Priority Review Expanded In Senate User Fee Bill
Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.
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The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
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Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.