S 4348 · 117th Congress · Health
FDASLA Act of 2022
Bill Progress
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Introduced2
Committee3
Senate Vote4
House5
EnactedLatest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.(2022-07-13)
Plain Language Summary
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Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 This bill modifies Food and Drug Administration (FDA) authority to collect certain fees. It also expands FDA authority to regulate certain products, including cosmetics. Among other provisions, the bill reauthorizes FDA authority to collect certain fees related to drugs, medical devices, and biosimilar biological products and modifies such fees, including the base fee amounts; establishes that certain requirements related to obtaining market approval for a new drug or a biosimilar may be satisfied using alternatives to animal testing, such as in vitro tests; authorizes the FDA to require that certain drugs be dispensed with a safe disposal system even if the system does not render a drug nonretrievable (current law requires such a system to render the drug nonretrievable); establishes time lines for the FDA to respond to requests to determine whether a drug is a therapeutic equivalent to an approved drug; modifies the accelerated process for approving products for a serious or life-threatening disease or condition and establishes an intra-agency coordinating council to ensure consist…
Summarized by Claude AI · Non-partisan · For informational purposes only
CBO Cost Estimate
Congressional Budget OfficeEstimated Direct Spending and Revenue Effects of S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022
Jul 21, 2022As Reported by the Committee on Health, Education, Labor, and Pensions on July 13, 2022
Full CBO report ↗Official non-partisan budget analysis by the Congressional Budget Office