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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.
 

Contact FDA

301-827-3028
301-827-3528 Fax
Advertising and Promotional Labeling Branch (APLB)

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike, HFM-602

Rockville, MD 20852-1448