S 4348 · 117th Congress · Health

FDASLA Act of 2022

Introduced 2022-05-26· Sponsored by Sen. Murray, Patty [D-WA]· Senate

Bill Progress

Introduced
2
Committee
3
Senate Vote
4
House
5
Enacted
Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.(2022-07-13)

Plain Language Summary

[AI summary unavailable — showing source text] 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 Office

Estimated Direct Spending and Revenue Effects of S. 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022

Jul 21, 2022

As 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

Cosponsors (1)

1 Republican