We work with marketers to help them promote in a compliant fashion.

The advertising and promotion of therapeutic and diagnostic products continues to evolve on both regulatory and technological fronts. Gardner Law is in tune with these changes and counsels clients on the labeling, advertising, and promotion of FDA-regulated products. We apply real-world industry experience obtained while working in industry.

We understand how to launch new products, develop prescriber and patient advertising campaigns, create websites, and use social media, paid search and micro blogging sites to promote products, while aligning with contemporary FDA thinking.

Gardner Law works with the Medical teams to design and implement policies that ensure lawful 1st Amendment-protected dissemination and communication of information, in a fashion that is consistent with FDA safe harbors.

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Advertising and Promotional Services offered by Gardner Law include:

  • Acting as a member of your copy-review team, i.e., Medical, Legal, and Regulatory (MLR) team, or Labeling and Advertising Review (LAR) Team
  • 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.
  • 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
  • Counseling companies on complex FDA requirements relating to responding to off-label questions and requests for off-label information
  • 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
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

Learn more about information on recent changes to the AdvaMed Code.

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