CBSA and our national partners support the renewal of the critically important User Fee Agreements, including the Pharmaceutical Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA). Without Congressional action, PDUFA and MDUFA will expire in September. CBSA supports policies that lead to greater consistency, predictability, and transparency in the Food and Drug Administration’s (FDA) review programs and help to bring safe, effective innovative therapies and technologies to patients.
Senate Health, Education, Labor & Pensions (HELP) Committee Ranking Member Richard Burr (R-NC) recently withdrew from renewal conversations due to his disagreements with policies added during the Committee markup and provisions in the House bill. It is reported that after he withdrew from conversations, he then introduced the Food and Drug Administration (FDA) Simple Reauthorization Act. This legislation would reauthorize the four expiring FDA user fee programs (prescription drug, generic drug, biosimilar and medical device) without…
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