Why Choose Reliant FDA Experts?

Label & Promo Material Review

Labels and promotional material regulation by the FDA applies to food, drugs, cosmetics, animal feed and treats, dietary supplements, biologics, radiation-emitting electronic products, and medical devices. The specific requirements depend on the type of product (drug, dietary supplement, device, etc.) and the type of label or promotional material. For example, it is important to identify the category of the material (institutional ad, help seeking/disease awareness communication, reminder ad, full product ad) when determining the regulations that apply to promotional material for a drug.

EXAMPLES OF REGULATED MATERIALS

  • Product Labels and Inserts
  • TV and radio commercials
  • Sales aids, journal ads, and patient brochures
  • Drug websites, blogs, e-details, webinars, tweets, posts, and email alerts
  • Oral presentations by: Sales Reps, Hired Spokespeople, Medical Science Liaisons

COMMON ISSUES, MISTAKES AND PITFALLS

  • Lack of distinction between “label” and “labeling”
  • Poor or insufficient documentation of the review
  • Use of contractors without qualification
  • Empty marketing materials

EXAMPLES OF THE HELP RELIANT CAN PROVIDE

  • Build a Sustainable Label & Marketing Material Review Program
  • Audit, Assess, and Provide Recommendations on an Existing Label & Marketing Material Program
  • Review and Provide Recommendations on a Label or Promotional Material For Drugs, Human and Animal Dietary Supplements, Pet Foods/Treats, and Human Foods.
  • Perform a Label & Promotional Material Review Gap Assessment

ASSOCIATED JOURNAL ARTICLES AND COMPLIANCE TIPS
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