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New and Revised FDA Import Alerts for Dec. 10
December 11, 2025 |FDA

On Dec. 10, the FDA posted new and revised versions of the following Import Alerts (after not having posted new ones for a number of days) on the detention without physical examination of:

New and Revised FDA Import Alerts for Dec. 8
December 9, 2025 |FDA

On Dec. 8, the FDA posted new and revised versions of the following Import Alerts (after not having posted new ones for a number of days) on the detention without physical examination of:

FDA Releases Final Guidance on Promotional Labeling for Prescription Biological Reference Products
December 9, 2025 |FDA

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, 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.