If you are an inventor, company, and/or investor, our attorneys can counsel you on the probable FDA regulatory status and approval pathway for your proposed new products and product concepts, as well as evaluate potential product exclusivities and life cycle evaluation, including IP protection issues. We can help you in determining the application type, and assisting with supporting data required for approval. We also draft meeting requests and help you prepare for meetings with the FDA and expert committees, and assist with the preparation of requests for determinations for combination products.
Our FDA Regulatory attorneys provide you with guidance throughout the entire approval process, and our team is skilled at resolving complications that may arise during FDA application review. We offer insight on the nature of applications and the applicability of FDA "exclusivity" and patent provisions. When your product goes to market, we can review your promotional statements and product claims, as well as support any life cycle management issues you may face.