Sandbox POV: FROM THE FDA: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers, Guidance for Industry

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Sandbox POV: FROM THE FDA: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers, Guidance for Industry

February 20, 2020

Our team at Sandbox has reviewed the draft FDA guidance on promotional labeling and advertising considerations for prescription biological reference and biosimilar products and provided an overview summary and bulleted Q&A for quick and easy review. These guidelines are draft but directional for promotional materials in development. Observations and Implications…

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FDA Outlook for 2020

Sandblogs

FDA Outlook for 2020

February 17, 2020

John Avellanet, an expert on data integrity and compliance practices for FDA, shared his insights on what the FDA will focus on in 2020.  This content is primarily for the device industry, but the key takeaways below are broadly applicable. 1. Move toward integrated enforcement FDA has evolved its public…

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