Amy B. Muhlberg, PhD U.S. FDA

Amy Muhlberg is a Staff Fellow at FDA in CDER’s Office of Pharmaceutical Quality in the Office of Policy for Pharmaceutical Quality, where she leads the development of guidance documents and responses to citizen petitions regarding drug product quality and manufacturing across the product lifecycle. She has two decades of FDA policy experience in trade associations, regulated industry, and on Capitol Hill. Amy earned her Ph.D. in Biochemistry from The Scripps Research Institute in La Jolla, California, and received her undergraduate degree in Biology from McGill University in Montréal, Canada.