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FDA: Draft Guidance Q&A on Promotional Labeling and Advertising for Reference or Biosimilar Products

Comment on the draft by Apr. 6, 2020 before work begins on the final guidance.

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The FDA released its draft guidance this week, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products—Questions and Answers.”

The 10-page guidance is intended for manufacturers, packers, distributors and others, offering considerations for developing labels and promotional materials for prescription reference and biosimilar products.

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