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User Fees

April 12, 2012 | Daily News

Congressional committees working on the reauthorization of FDA user fees, including a fee for the health reform-created biosimilars review pathway, could begin marking up bills the last week in April, sources said, with the Senate health committee planning to convene a markup the week of April 23. A bipartisan draft is expected from the House Energy and Commerce Committee in the coming weeks, a source said, noting that both chambers still have to address gaps in their legislative measures.

April 04, 2012 | Daily News

Draft drug reform legislation released by the Senate health committee Wednesday (April 4) instructs FDA to release long-awaited social media guidance, with the bill also including previously introduced measures codifying the accelerated approval process, creating a new breakthrough drug designation to speed up development of promising medications and expanding the agency's use of experts for advice on rare diseases.