FDA Reauthorization Act: Drug and Medical Device Fees Extended
This act extends user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products until 2027. The changes aim to expedite the approval process for new products, potentially leading to faster access to innovative therapies and medications for citizens. It also introduces new rules regarding fees and their use by the Food and Drug Administration (FDA).
Key points
Extends FDA funding through fees from pharmaceutical and medical device companies until 2027.
Modifies how fees are calculated and used, aiming to streamline drug and device approval processes.
Introduces new definitions and exceptions for fees, such as for skin-test diagnostic products.
Reauthorizes programs supporting the development of pediatric drugs, orphan drugs, and innovative medical devices.
Status:
Expired
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