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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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

1401 Rockville Pike, HFM-602

Rockville, MD  20852-1448

 

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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Contact FDA

Advertising and Promotional Labeling Branch (APLB)

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research

Food and Drug Administration

1093 New Hampshire Avenue

WO Building 71

Silver Spring, MD 20993