22. January 2016 FDA Regulation & Personalized Medicine D’Souza R. “FDA Regulation and Personalized Medicine.” Regulatory Focus. January 2016. Regulatory Affairs Professionals Society. tagPlaceholderTags: clinical, medical, device, FDA, regulatory, registration, drug, IND, IDE, biologic, JAN2016, biotechnology, strategy, labeling, submission, 3D, printing, development