U.S. Food and Drug Administration
Silver Spring, Maryland
Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 25 years of experience producing numerous research manuscripts, review articles, book chapters and patents in pharmaceutical product development. Dr. Raney has been a researcher and adjunct professor within academia, a principal or sub investigator on over 400 pharmaceutical product development studies, has held senior management roles in industry, and serves as an expert for the U.S. Pharmacopeia. He is currently the Lead for Topical and Transdermal Drug Products in the FDA’s Office of Generic Drugs where he directs multi-million dollar research programs, overseeing FDA’s research collaborations with international experts to develop cutting edge technology, novel study designs, and innovative statistical analyses to make complex generic drug development more efficient for topical and transdermal products. He also leads the FDA’s engagements with developers of complex topical and transdermal generic products, overseeing matters in Citizen Petitions, Controlled Correspondences, Pre-ANDA meetings and ANDA submissions as well as the development of FDA Guidances. Dr. Raney holds a Bachelor’s in Molecular Biophysics & Biochemistry from Yale University, a Master’s in Biology from Marshall University, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.
Wednesday, November 4, 2020
4:00 PM – 4:15 PM ET