News & Analysis as of

Department of Health and Human Services (HHS) CARES Act Over The Counter Drugs (OTC)

Snell & Wilmer

2024 End-of-Year Plan Sponsor “To Do” List (Part 1) Health and Welfare

Snell & Wilmer on

We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate SW Benefits Updates. This Part 1 covers year-end health and welfare plan issues. Parts 2,...more

Arnall Golden Gregory LLP

OTC Monograph Reform – Takeaways from FDA’s Webinar on Expedited Administrative Orders

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter...more

Arnall Golden Gregory LLP

OTC Monograph Fees Announced… Not So Fast!

On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter Monograph User Fee Act (OMUFA) Program for Fiscal Year 2021. Reed Tech...more

Hogan Lovells

HHS forces FDA to withdraw notice for OTC user fees and creates new exemptions

Hogan Lovells on

On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection efforts” related to the Over-the-Counter (OTC) Drug Monograph User Fee...more

King & Spalding

FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates

King & Spalding on

Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for...more

Husch Blackwell LLP

Holiday Confusion For The Over-The-Counter Drug Industry: FDA Announces OTC Fee Schedule That HHS Quickly Withdraws

Husch Blackwell LLP on

On December 29, 2020, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice the 2021 fee schedule for its Over-the-Counter Monograph Drug User Fee Program. That user fee program was an addition...more

Akin Gump Strauss Hauer & Feld LLP

The Health Care Industry and the CARES Act: Insight and Next Steps

While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more

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