Tag: PDUFA VII

PDUFA VII

Legislative

Delays Add Pressure to User Fee Legislative Process

Delays Add Pressure to User Fee Legislative Process

Feb. 14, 2022 – Negotiations for prescription drug and medical device user fee legislation are running behind schedule and legislators are concerned about the timeline for the Prescription Drug User Fee Amendments VII (PDUFA VII), the Medical Device User Fee Amendments (MDUFA) and other user fee bills. Because the Food and Drug Administration (FDA) receives […]

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Regulatory/FDA

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

Oct. 11, 2021 – The Food and Drug Administration (FDA) will hold a virtual public meeting Nov. 2 to discuss the proposed changes it would like to make during the reauthorization process for the Biosimilar User Fee Act for fiscal years 2023 through 2027 (BsUFA III). The current legislation, BsUFA II, will expire in September […]

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Legislative

FDA Shares Drug Review Priorities, Sets Date for Public Meeting

FDA Shares Drug Review Priorities, Sets Date for Public Meeting

Sept. 10, 2021 – The Food and Drug Administration (FDA) recently issued a commitment letter regarding the next iteration of the Prescription Drug User Fee Act (PDUFA VII) that spells out its review timeframes, performance goals and modernization priorities for fiscal years (FYs) 2023-2027. Among these priorities are enhancements related to expediting drug development, expanding decision […]

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