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Mintz - Health Care Viewpoints

FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round

Mintz - Health Care Viewpoints on

As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight...more

Akin Gump Strauss Hauer & Feld LLP

Senate Passes Long-Awaited FDA User Fee Package

Akin Gump Strauss Hauer & Feld LLP on

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

Mintz - Health Care Viewpoints

FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board

Mintz - Health Care Viewpoints on

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee...more

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