Yesterday, the U.S. House of Representatives passed by voice vote, H.R. 2430, the FDA Reauthorization Act.Yesterday, the U.S. House of Representatives passed by voice vote, H.R. 2430, the FDA Reauthorization Act.
The bill reauthorizes Food and Drug Administration (FDA) user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products through fiscal year 2022. It also includes provisions to accelerate the review and approval of generic drugs, allow certain classes of medical devices to be reviewed by accredited persons and laboratories, and includes the Over the Counter Hearing Aid Act, which provides for the federal regulation of over-the-counter hearing aids for adults with perceived mild-to-moderate hearing loss.