FDA Issues Revised Guidance on Promotion of Biosimilars

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FDA Issues Revised Guidance on Promotion of Biosimilars

J.W. Schomisch

April 26, 2024 at 10:12 AM EST

The FDA issued revised draft guidance April 24 to fulfill the Biosimilar User Fee Amendments of 2022 commitment to publish draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products. The revised guidance replaces draft guidance released in 2020. The revised draft guidance – Promotional Labeling and Advertising Considerations ... Read More

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FDA Issues Revised Guidance on Promotion of Biosimilars

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