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Outsourcing Draft Guidance

BakerHostetler

FDA Clarifies Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act

BakerHostetler on

On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more

Latham & Watkins LLP

EIOPA Issues Final Guidelines on Outsourcing

Latham & Watkins LLP on

The final guidelines create new obligations for insurers that will impact cloud outsourcing arrangements. On 6 February 2020, the European Insurance and Occupational Pensions Authority (EIOPA) published its final...more

King & Spalding

FDA Issues Three Draft Guidance Documents For Drug Compounders

King & Spalding on

On April 15, 2016, the U.S. Food and Drug Administration (“FDA”) issued three new draft guidance documents related to human drug compounding under the Food, Drug, and Cosmetic Act (“FD&C Act”), as amended by Title I of the...more

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

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