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Exemptions › Supply Chain › Food and Drug Administration (FDA)

Epstein Becker & Green

FDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners

Epstein Becker & Green on

In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

Akin Gump Strauss Hauer & Feld LLP on

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

McDermott Will & Emery

TTB and FDA Relax Restrictions on the Production of Hand Sanitizers by Alcohol Manufacturers

McDermott Will & Emery on

With the increasing pace of the spread of the Coronavirus (COVID-19) and the related emergent need to increase the available supply for hand sanitizer products across the United States, the Alcohol and Tobacco Tax and Trade...more

Benesch

I’m Kind of a Big Dill: Current Challenges in Transporting Food Under FSMA

Benesch on

Since the U.S. Food and Drug Administration (“FDA”)’s publication of the Final Rule regarding Sanitary Transportation of Human and Animal Food on April 6, 2016, 21 CFR 1.900, et seq. (the “STF Rule”), there has been an...more

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