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Pharmaceutical Industry › Food and Drug Administration (FDA) › Memorandum of Understanding

Quarles & Brady LLP

Federal Court Deals Blow to FDA’s Compounding MOU

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On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more

McGuireWoods LLP

Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series

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In episode three of McGuireWoods’ Edible Bites video series, the newly released U.S. Food and Drug Administration compounding pharmacy memorandum of understanding is hashed out, including discussion on key provisions and...more

Bass, Berry & Sims PLC

FDA Announces Availability of the Standard Memorandum of Understanding for Signature by States – the 365 Day Countdown to 5%...

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The U.S. Food and Drug Administration (FDA) announced October 26 the availability for the signing of the final standard Memorandum of Understanding Addressing Certain Distribution of Compounded Human Drug Products (MOU)...more

Hogan Lovells

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general...

Hogan Lovells on

On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law...more

Husch Blackwell LLP

FDA Publishes Revised Draft MOU Addressing State And Federal Oversight Of 503A Compounding Pharmacies

Husch Blackwell LLP on

On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded...more

Akin Gump Strauss Hauer & Feld LLP

FDA Releases Revised Memorandum of Understanding That Would Ease Restrictions on Interstate Shipment of Compounded Drugs

Akin Gump Strauss Hauer & Feld LLP on

• FDA has put out a new draft MOU for stakeholders to review and provide comments over the next 90 days. • If a state enters into the proposed MOU, pharmacies within its borders would be allowed to distribute up to 50...more

BakerHostetler

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

BakerHostetler on

Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...more

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