Personalized Medicine FDA and Regulatory Issues

FDA regulatory issues for personalized medicine begin with the requirements for individual personalized medicine products: drugs, biologics, and devices. Key issues you must consider are the investigation phase of the product and developing appropriate clinical investigations to demonstrate safety and effectiveness of your product for the limited patient population. This is a new frontier for the FDA — one that will require particular care and guidance if you are to navigate it successfully.

The FDA Regulatory members of our Personalized Medicine Practice counsel and advise you on drug, biologic, and medical device development as well as other regulatory matters subject to FDA jurisdiction. Foley counsels clients seeking review and approval from the FDA and its counterpart authorities abroad in all phases of the product development cycle including strategic business planning, product development and testing, compliance and enforcement and federal and state lobbying. Within these critical areas we advise on the following:

• Advising on the regulatory pathways for companion diagnostics and therapeutics
• Addressing patent listing and marketing exclusivity issues
• Preparing scientific information related to competitive disputes
• Advising on issues related to advertising, marketing, and distribution
• Preparing and reviewing Investigational Device Exemptions, 510(k), and PMA submissions to meet FDA requirements
• Strategizing on pre-investigational new drug (IND) meeting requests, including preparing and leading pre-IND meetings between the sponsor and the FDA; and preparing and reviewing INDs, NDAs, and ANDAs

In addition, we help craft responses, develop and implement corrective action programs, and assist you in determining the scope of any necessary recall actions, requisite recalls, and corrective measures in the event of inspectional observations and/or warning letters issued by the FDA. With a strong regulatory team located in our Washington, D.C. office, we are well equipped to deal with FDA headquarters’ compliance offices, as well as the regional, district, and resident field offices.