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Manufacturers › Pharmaceutical Industry › Clinical Laboratory Testing

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

McDermott Will & Emery on

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Alston & Bird

FDA Issues New Guidance on Nitrosamine Impurities in APIs and Drug Products

Alston & Bird on

Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do...more

Knobbe Martens

FDA Provides Guidance on 3D-Printed Medical Device Products

Knobbe Martens on

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

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