S 2516 · 112th Congress · Health
Food and Drug Administration Safety and Innovation Act
Bill Progress
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Introduced2
Committee3
Senate Vote4
House5
EnactedLatest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 389.(2012-05-07)
Plain Language Summary
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Food and Drug Administration Safety and Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revises requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. Prescription Drug User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect prescription drug fees to support the FDA drug development and human drug application review process. Medical Device User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary to assess and use fees for expediting the review process for medical device applications and for assuring the safety and effectiveness of such devices. Generic Drug User Fee Amendments of 2012 - Directs the Secretary to assess and collect human generic drug user fees through FY2017, including a fee for drug applications pending on October 1, 2012, a drug master file fee, a generic drug facility fee, and an active …
Summarized by Claude AI · Non-partisan · For informational purposes only
CBO Cost Estimate
Congressional Budget OfficeS. 2516, Food and Drug Administration Safety and Innovation Act
May 11, 2012As reported by the Senate Committee on Health, Education, Labor, and Pensions on May 7, 2012
Full CBO report ↗Official non-partisan budget analysis by the Congressional Budget Office