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24
Apr
Revised QA Document on Promotional Activities for Biosimilars Released by FDA - Lachman Blog

Revised Q&A Document on Promotional Activities for Biosimilars Released by FDA

By    Apr 24, 2024    Advertising Biologics Biosimilars Labeling Promotional material Regulatory Affairs

Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath! This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The […]

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03
Feb
Developing marketing strategy. Development of effective solution.

Promotional Labeling is the Target of New Q&A Document on Biosimilars and Reference Products

By    Feb 03, 2020    Advertising Biologics Biosimilars BLA Labeling Promotional material

Today, the FDA released a guidance document titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (here).  The document provides the FDA’s responses to eight questions designed to help firms assure that they do not run afoul in advertising or promotion when describing similarities and differences between the […]

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