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Guidance Update Biologics Pharmaceutical Industry

Goodwin

FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars

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On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more

Goodwin

FDA Answers New Questions on Foreign Trial Sites Operating Under INDs

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On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more

Seyfarth Shaw LLP

FDA Issues Guidance Documents Directed to Blood Donations as Part of COVID-19 Public Health Emergency Measures

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To address critical shortages of blood and plasma during the COVID-19 pandemic, the U.S. Food and Drug Administration (the “FDA”) released several guidance documents on April 2, 2020.  ...more

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