FDA Releases Final Guidance on Promotional Labeling for Prescription Biological Reference Products
The FDA says final guidance for the industry is available on promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products, according to a Federal Register notice. The guidance addresses questions that manufacturers, packers,…
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distributors and their representatives may have when developing FDA-regulated promotional labeling and advertisements for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act, the FDA said.