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Pharmaceutical Industry › Food and Drug Administration (FDA) › Fees

BakerHostetler

AD-ttorneys@law - May 2022

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NAD Won’t Rename Supplement Maker - Innovix Pharma loses on product claims but gets to keep its calling card. Nerding Out - Aside from the intricacies of advertising, advertising law, and the disputes engendered...more

Goodwin

FDA Releases Biosimilar User Fee Act Rates for Fiscal Year 2022

Goodwin on

Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2022 fiscal year, which runs from October 1, 2021 through September 30, 2022. The FDA determined these rates pursuant to the Food and Drug...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

Sheppard Mullin Richter & Hampton LLP on

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!

Arnall Golden Gregory LLP on

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

Goodwin

White House Releases Policy Statement Calling For Elimination Of Federal Funding For FDA’s Pre-Market Review Costs

Goodwin on

The White House released a statement of administration policy on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize the FDA’s user fee programs, including FDA’s biosimilar...more

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