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S 4348 117th Congress Senate Health Administrative law and regulatory procedures Administrative remedies Allergies Animal protection and human-animal relationships Business records Child health Congressional oversight Cosmetics and personal care Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Drug trafficking and controlled substances Employee hiring Executive agency funding and structure Federal preemption Food and Drug Administration (FDA) Food industry and services Food supply, safety, and labeling Government employee pay, benefits, personnel management

FDASLA Act of 2022

Introduced: May 26, 2022 Introduced by: Murray, Patty Democratic · Washington See on congress.gov
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 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 13, 2022
Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.
Jul 13, 2022
Committee on Health, Education, Labor, and Pensions. Reported by Senator Murray with an amendment in the nature of a substitute. Without written report.
Jun 14, 2022
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
May 26, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 26, 2022
Introduced in Senate
 Plain-English summary Congressional Research Service

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 consistent and appropriate use of the process;
  • requires additional regulation of cosmetics, including by requiring manufacturers to register manufacturing facilities and each cosmetic product with the FDA;
  • requires dietary supplement manufacturers to provide to the FDA certain information, including a list of all ingredients, about each dietary supplement that it markets;
  • requires an in vitro clinical test to receive FDA premarket approval or a technology certification (or be otherwise exempted) before being introduced into interstate commerce; and
  • requires the FDA to temporarily relax certain premarket requirements for a manufacturer that intends to market a new infant formula.
What's happening now July 13, 2022

Placed on Senate Legislative Calendar under General Orders. Calendar No. 444.

 Committees of jurisdiction 1