Food and Drug Amendments of 2022
This bill reauthorizes Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices.
Specifically, the bill reauthorizes through FY2027 the FDA user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.
The bill also requires the development of action plans and related reporting to increase the diversity of participants in clinical trials.
In addition, the bill requires the FDA to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).
The bill also (1) establishes requirements and reauthorizes programs to support the development of specific categories of drugs and devices (e.g., pediatric drugs) and inspections of drug manufacturing facilities; and (2) establishes and revises requirements relating to the approval of drugs and devices, including requirements for postapproval studies and guidance about using real-world evidence to support drug and device applications.