Journal of Pharmaceutical Sciences and Drug Development

David Gortler

David Gortler
Professor of Basic science and clinical pharmacology


Dr. David Gortler PharmD FCCP is a professor of Basic science and clinical pharmacology. He is a pharmacology expert and drug safety expert who has worked in investigational medicine and drug development for 20 years. David Gortler did his residency through the New York/Columbia Presbyterian Hospital following which he did his specialty residency and postdoctoral fellowship in vascular medicine and investigational medicine work at The Yale University School of Medicine where he conducted multiple clinical trials. His investigational medicine career continued as an investigational medicine research scientist at Pfizer Inc. in both New England and New York City where Dr. David Gortler designed, composed and supervised and managed a team of scientists conducting investigational medicine clinical trials. While working at Pfizer in New York, Dr. David Gortler was offered a faculty position at Yale University as an assistant professor at the School of Medicine where he taught classes to medical students and PhD students in drug development clinical and basic science Pharmacology. He was later recruited by and accepted a position at the FDA where he worked as a Medical Officer/Senior Medical Analyst. At the FDA, He was directly responsible for approving or not approving new drug applications submitted by drug companies and monitoring their ongoing safety. He was also in charge of making labeling changes for existing marketed drugs based on ongoing and new clinical trial findings and AERS database /FAERS database reports. Dr. David Gortler is a member of the FDA consulting group Former where he serves a Neuropharmacology expert and FDA expert in FDA policy, FDA Law and drug safety to FDA Lawyers and drug companies who need assistance with complex FDA policy questions, including the AERS database /FAERS database

Research Interest

Lipid metabolism; cholesterol metabolism; endocrinology; vaccination; bioethics; compassionate use; neuropharmacology; epidemiology; FDA Policy; FDA Law; pharmacology; pharmacovigilance (AERS/FAERS); drug safety and drug development.