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Final Guidance Labeling Draft Guidance

McDermott Will & Emery

FDA Releases Final Guidance on New Dietary Ingredient Notification Procedures and Timeframes

McDermott Will & Emery on

On March 5, 2024, the US Food & Drug Administration (FDA) released final guidance titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance is meant to...more

King & Spalding

FDA Finalizes Guidance on Presenting Quantitative Efficacy and Risk Information in DTC Promotion

King & Spalding on

On June 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued final guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (“Quantitative...more

Foley Hoag LLP

FDA Updates Select Q&As on Biosimilar Regulation

Foley Hoag LLP on

The Food and Drug Administration (FDA) updated a final guidance and a companion draft guidance (the “first draft guidance”) providing answers to questions related to the agency’s regulation of biosimilar products and its...more

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