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FDA: Draft Guidance Q&A on Promotional Labeling and Advertising for Reference or Biosimilar Products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The FDA released its draft guidance this week, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products—Questions and Answers.”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.

The Agency notes that goal of the guidance document is to ensure that data and information about these products is “truthful and non-misleading as required under the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations.

“FDA has and will continue to play a critical role in facilitating increased access to biosimilars, by supporting robust and timely competition, which can help increase patient access and reduce cost burdens on patients and our health care system. In addition, FDA wants to help ensure the United States remains a driving force in medical innovation, and part of that role includes helping to ensure communication of truthful, non-misleading, and balanced information about biological products, by drug manufacturers, packers and distributors and those acting on their behalf.”

For the guidance document PDF, click here.>>>

Comment by Apr. 6, 2020 at this link.>>>

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