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Articles by Kasia Foster
FDA Finalizes Its SIUU Guidance: An Analysis Of The Key Changes From The 2023 Draft Guidance
At the start of the new year, the U.S. Food and Drug Administration (FDA) finalized its October 2023 guidance (the Final SIUU Guidance) on scientific information on unapproved use(s) of approved/cleared medical product communications (SIUU communications).1 The Final SIUU Guidance outlines FDA's policy on firm-initiated communications of scientific information of unapproved use(s) of approved medical products to health care providers and provides the contours of the agency's enforcement...
FDA Finalizes Its SIUU Guidance: An Analysis of the Key Changes From the 2023 Draft Guidance
At the start of the new year, the U.S. Food and Drug Administration (FDA) finalized its October 2023 guidance (the Final SIUU Guidance) on scientific information on unapproved use(s) of approved/cleared medical product communications (SIUU communications).1 The Final SIUU Guidance outlines FDA’s policy on firm-initiated communications of scientific information of unapproved use(s) of approved medical products to health care providers and provides the contours of the agency’s enforcement...
5 Takeaways From FDA's Biosimilars Promotion Guidance
By Abeba Habtemariam, Mahnu Davar and Kasia Foster (May 9, 2024, 6:48 PM EDT) -- On April 24, the U.S. Food and Drug Administration released a revised draft guidance regarding promotional labeling and advertising considerations for prescription biological reference products, biosimilar products and interchangeable biosimilar products.... Law360 is on it, so you are, too.
Five Key Takeaways From FDA's Updated Draft Guidance On Biosimilars Promotion
On April 24, 2024, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry" (Draft Biosimilar Promotion Guidance or the Revised Draft Guidance).
Five Key Takeaways From FDA
On April 24, 2024, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry” (Draft Biosimilar Promotion Guidance or the Revised Draft Guidance).
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