Sharon Blinkoff

Locke Lord LLP

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New FDA User Fee Bill Contains Rider ‎That Would Permanently Alter FDA’s Regulation ‎of Cosmetics

On May 26, Senators Murray and Burr introduced S. 4348 (pg. 97). The primary focus of the bill was to pass reauthorizations of FDA’s critical user fee programs for drugs, medical devices and biologics, which are scheduled to...more

6/13/2022 / Biologics , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , User Fees

FDA Announcement on User Fees for the Over-the-Counter (OTC) Drug Program for FY 2021

On March 26, 2021, the FDA announced it will collect OTC user fees for Fiscal Year 2021 from owners of OTC Monograph Facilities that were in operation for the period from January 2020 through December 2020. As we previously...more

3/29/2021 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Over The Counter Drugs (OTC) , User Fees

Case Closed: Facilities That Manufactured Hand Sanitizers During the Pandemic Will Not Be Charged User Fees

On January 12, 2021, the Department of Health and Human Services issued yet another Federal Register notice announcing that Persons that Entered the Over the Counter drug market to supply hand sanitizers during the COVID-19...more

1/14/2021 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Manufacturers , User Fees

HHS Withdraws FDA’s “Arbitrary, Surprise” OTC User Fee and ‎Proposals for FY 2021

As is typical with the FDA, the Agency chose the end of the year to publish the fees it intended to ‎collect from over-the-counter (OTC) monograph drug manufacturers under the OTC Monograph User ‎Fee Act (OMUFA). In its...more

1/12/2021 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Pharmaceutical Industry , User Fees

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