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Manufacturers › New Guidance › FDA Approval

Cozen O'Connor

FDA Encourages Food Manufacturers to Phase Out FD&C Red No. 3 Ahead of 2027 Deadline

Cozen O'Connor on

On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more

Schwabe, Williamson & Wyatt PC

Recent FDA Guidance on the Distribution, Use, and Importation of Disposable Filtration Masks and Face Shields

Schwabe, Williamson & Wyatt PC on

As the COVID-19 outbreak expands, supply chains have been stressed for general use face masks, surgical masks, and similar disposable devices for filtering airborne particulates, as well as medical face shields. To help...more

Morgan Lewis

COVID-19: Transforming Your Manufacturing Operations to Supply Critical-Need Medical Devices

Morgan Lewis on

The White House is reportedly in discussions with US auto companies to aid in the coronavirus (COVID-19) relief effort by producing ventilators, and some US distilleries have already switched manufacturing operations to make...more

Epstein Becker & Green

OIG Permits Manufacturer of Personalized Medicine Drug to Cover Patients’ Travel, Lodging, and Other Expenses

Epstein Becker & Green on

On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02, approving an arrangement under which a pharmaceutical manufacturer provides...more

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