Accelerated Approval Bill In Senate Tracks House Draft, But With More Of A Nod To FDA
This article was originally published in The Pink Sheet Daily
The Senate measure adds a provision on breakthrough therapies and specifies that accelerated approval provisions do not alter substantial evidence standard used to approve drugs.
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PhRMA’s assistant general counsel says that FDA’s draft might increase expenses because of the need to submit final ads in advance and the potential to be asked for extensive revisions.
Reps. Stearns and Towns want the Senate draft to more closely align with their FAST Act by adding language that would allow greater flexibility for development of rare disease treatments.
An agreement with the European Medicines Agency likely would be necessary for therapies designated as breakthroughs to ensure expedited clinical program would be accepted in both jurisdictions.