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Manufacturing Facilities Department of Health and Human Services (HHS)

Arnall Golden Gregory LLP

This Is Not A Drill . . . FDA Publishes Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021

On March 26, 2021, the Food and Drug Administration (FDA) issued a new Federal Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021.  As we...more

Rivkin Radler LLP

In NY, CBD Manufacturers And Distributors Now Must Be Licensed

Rivkin Radler LLP on

Governor Andrew Cuomo announced that the New York State Department of Health is now accepting applications from businesses seeking licensure to operate as cannabinoid hemp processors, retailers, or distributors. Cannabinoid...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

McDermott Will & Emery

Special Fraud Alert: OIG Raises Concerns with Speaker Programs

McDermott Will & Emery on

In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more

Sheppard Mullin Richter & Hampton LLP

President Trump’s Executive Order Mandating the Purchase of U.S. Drugs Evokes Criticism

On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of...more

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