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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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About the Advertising and Promotional Labeling Branch (APLB)

APLB is responsible for protecting the public health by

  • Regulating advertising and promotional labeling materials for CBER products to ensure that the information about the risks and benefits of regulated products are communicated in a truthful, accurate, science-based, non-misleading and balanced manner and is in compliance with pertinent federal laws and regulations
  • Evaluating proposed proprietary names to avoid potential medication errors related to look-alike and sound-alike proprietary names and mitigating other factors that contribute to medication errors, such as unclear label abbreviations, acronyms, dose designations, and error prone label and packaging design 

What we do

  • Review draft and final professional and direct-to-consumer (DTC) advertising and promotional labeling materials submitted for licensed biological products, including vaccines, allergenic extracts, blood products, gene therapy products, and certain medical devices and test kits regulated by CBER. 
  • Review promotional materials to ensure that information about the product’s risks and benefits is communicated in a truthful, non-misleading, and balanced manner, and is in compliance with pertinent federal laws and regulations
  • Evaluate complaints about alleged promotional violations
  • Attend professional meetings and conferences and pharmaceutical conventions to monitor promotional exhibits and activities
  • Evaluate proposed proprietary names for potential medication errors related to name confusion from look-alike and sound-alike proprietary names
  • Evaluate cartons, container labels and other product packaging to avoid unclear label abbreviations, acronyms, dose designations, and error prone label and packaging design 
  • Provide consultative reviews of proposed product labeling (PI), Patient Prescribing Information or Patient Package Insert (PPI), and Medication Guides

 

 

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