FDA CALL FOR COMMENTS ON OFF-LABEL COMMUNICATIONS

U.S. Biosimilar Litigation News

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications about unapproved uses of their approved/cleared medical products, including biologics.

The public hearing will be held on November 9 and 10 at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002, and persons seeking to attend or present must be registered by October 19. Any written comments will be accepted, however, until January 9, 2017.

For more information, stay tuned for Big Molecule Watch updates.

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