FDA Update: Current Challenges of the Changing Regulatory Environment

FDA Update: Current challenges of the changing regulatory environment.

There have been several major leadership changes in the US FDA in the past few months. This new leadership has also communicated several new policy directions. The Department of Health and Human Services (HHS) has also proposed major changes in NIH, CDC, and other agencies that work closely with the FDA. Staff reductions and budget cuts are always concerning. What does all of this mean for the day-to-day work of medical product/drug development? How will the efforts to reduce regulatory burden impact drug development? What trends are we seeing from the FDA? What do we know so far, and what can we expect going forward? What is not likely to change?

These and other topics will be discussed.

About the Speaker – Mary Ellen Cosenza, PhD, DABT, ATS, ERT, RAC

Mary Ellen Cosenza is a regulatory toxicology consultant with over 35 years of leadership experience in the biopharmaceutical industry including 20 years at Amgen. Mary Ellen is well published in the field of biological drug development. Mary Ellen is a Past-President of the American College of Toxicology (ACT) and is currently the Treasurer of the International Union of Toxicology (IUTOX). She is also an adjunct professor at the University of Southern California.

Mary Ellen received her BA in Biology and Chemistry from Queens College, CUNY and her MS and PhD in Toxicology from St. John’s University, New York, and her MS in Regulatory Science from the University of Southern California, Los Angeles.

Mary Ellen is a Diplomat of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences (current President), member of the Society of Toxicology (SOT), Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS) and holds Regulatory Affairs Certification for both the U.S. and EU. Mary Ellen is a European Registered Toxicologist (ERT) via the Royal Society of Biology, UK.