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  3. Development & Approval Process (CBER)
  4. Labeling for CBER-Regulated Products
  5. Submitting a Complaint about Advertising & Promotional Labeling of Biologic Products
  1. Labeling for CBER-Regulated Products

Submitting a Complaint about Advertising & Promotional Labeling of Biologic Products

The Advertising & Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER) reviews complaints about promotional activities or materials related to CBER-regulated products. Anyone within or outside FDA (e.g., FDA employees, consumers, health care professionals,companies, etc.) may submit a complaint to the APLB Branch Chief at the following address: 

FDA/CBER
OCBQ/DCM/APLB
10903 New Hampshire Avenue
WO Building 71
Silver Spring, MD 20993

The complaint should include:

  • A cover letter describing specific details of the alleged violative advertising and promotional labeling material(s) or promotional activity;
  • Two copies of the alleged violative advertising and promotional labeling material(s);
  • Any supporting information regarding the alleged violative advertising and promotional labeling material(s);
  • The complainant's contact information.
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