News & Analysis as of

Legislative Riders Food and Drug Administration (FDA)

McDermott Will & Emery

CARES Act Reforms to Address Drug and Device Shortages and Updates to the OTC Drug Monographs

McDermott Will & Emery on

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more

Mintz - Health Care Viewpoints

Coronavirus Relief Bill Includes Surprise Addition: OTC Monograph Reform Bill Becomes Law

As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph reform bill into law on March 27, 2020....more

Mintz - Health Care Viewpoints

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

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

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

Congress Returns for June Session to Face AHCA, User Fees and More

Congress returns from its Memorial Day recess to four full weeks of legislative activity. The drama of the American Health Care Act (AHCA) now hangs over the Senate. The House will return to its regular work once they advance...more

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – May 2017

We are half way through May – are we having fun yet? There is a lot of activity this week in addition to ongoing talks in the Senate regarding their version of the American Health Care Act. The reauthorization of FDA User...more

Mintz - Health Care Viewpoints

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

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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