Ad Promo Review

Promote in a compliant fashion.

Gardner Law counsels clients on the labeling, advertising, and promotion of FDA-regulated products. Our attorneys apply real-world industry experience when reviewing product launch plans, prescriber and patient advertising campaigns, websites, social media, and paid search.

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Ad Promo Review

Out attorneys can sit on your promotional and medical review committees to ensure your product communications comply with the law.

Representative matters:

  • Analyzing promotional claims to ensure they align with the cleared or approved intended use of a product; e.g., review brochures, websites, social media, direct-to-consumer advertising programs (help-seeking and reminder ads), education materials, TV ads, press releases, booth graphics, etc.
  • Counseling companies on complex FDA requirements relating to responding to off-label questions and requests for off-label information
  • Providing advice to companies with cleared or approved general intended uses; as well as representing clients subject to Warning Letters for specific claims that allegedly exceed a cleared or approved general intended use
  • Designing lawful proactive off-label dissemination strategies
  • Training medical device representatives on what to avoid while covering surgical cases
  • Responding to regulators and competitors; as well as drafting trade complaints to regulators and competitors
  • Providing benchmarks on company promotional practices, advertising claims, and compliance program design
  • ‚Ä®Training staff on FDA regulations
  • Reviewing your existing labeling and advertising policy and procedures for the preparation of Sales, Marketing, and Reimbursement materials; or designing and implementing a labeling and advertising review policy and procedure
  • Drafting disclosures and disclaimers
  • Reviewing reimbursement materials and tools