What a manufacturer (or its agent) states about its drug, product, or medical device must be carefully scrutinized for accuracy, fair balance, and regulatory compliance. Claims made in advertising and promotional materials can form the basis of costly FDA/FTC enforcement actions, competitor lawsuits, consumer protection actions, and products liability claims.
Morningstar Law Group has experienced FDA and healthcare regulatory lawyers with deep experience and expertise in advising companies on advertising and promotion issues.
FDA Advertising and Promotion Services
Our FDA and healthcare regulatory attorneys assist clients on matters such as:
- Reviewing product claims, multi-channel marketing, and new and/or novel sales tactics
- Serving as a member of (or advisor to) your medical, legal, and regulatory (MLR) review committee to mitigate the risk that product claims run afoul of FDA regulations
- Developing and implementing a new or improved MLR review process
- Training on FDA rules, regulations, and guidelines relating to advertising and promotion
We recognize that every company and every product is unique, so our regulatory attorneys work closely with you to understand the characteristics of your business and product portfolio. This enables us to offer highly effective, efficient, and practical legal advice on FDA advertising and promotion issues.