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Fees Over The Counter Drugs (OTC)

Snell & Wilmer

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

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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

ArentFox Schiff

FDA Announces New Fees for Manufacturers of Over-the-Counter Drugs

ArentFox Schiff on

As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more

Womble Bond Dickinson

FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees

Womble Bond Dickinson on

On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more

Sheppard Mullin Richter & Hampton LLP

FDA Announces Facility Fees for OTC Drug Manufacturers

On Friday, March 26, 2021, FDA published a Federal Register notice, “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC)...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

Wiley Rein LLP

OTC Drug User Facility Fees – Don’t Miss the Changes!

Wiley Rein LLP on

On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts...more

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