Objectives
Understand the FDA’s organization and role in regulating medical products, including drugs, biologics, and medical devices, and the mission, vision, and core functions of the FDA’s Office of Pediatric Therapeutics.
Differentiate INDs, IDEs, NDAs, BLAs, and PMAs and understand the FDA’s role generally in the medical product development lifecycle.
Highlight the appreciation of the unique regulatory considerations that apply to pediatric clinical therapeutics trials.
References
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-new-drug-applications-prepared-and-submitted-sponsor-investigators
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-decisions-investigational-device-exemption-clinical-investigations
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ethical-considerations-clinical-investigations-medical-products-involving-children
Speaker(s) Bio
Melanie Bhatnagar is the Associate Director for Pediatric Education and Outreach within the Office of Pediatric Therapeutics (OPT) at the U.S. Food and Drug Administration. In her role overseeing OPT’s Pediatric Education and Outreach Program, Dr. Bhatnagar works to promote, enhance, and drive cross-cutting educational activities and initiatives to further knowledge on important issues pertaining to children’s health. She also works to build and strengthen strategic partnerships to drive and inform scientific and policy priorities to advance children’s health. Dr. Bhatnagar received her undergraduate degree from the University of Virginia and her medical doctorate from the George Washington University School of Medicine and Health Sciences. She completed her pediatric residency training at the University of Maryland and, prior to joining the FDA, spent several years in private clinical practice as a general pediatrician.
DCOC Contact Information
Catrice Banks-Johnson
Email: crbanksjohnson@uams.edu
DeAnn Hubberd
Email: DEHubberd@uams.edu
You can download an official transcript from your CloudCME profile (https://uams.cloud-cme.com/default.aspx) or you can request a copy of your transcript at https://ce.uams.edu/transcript-request-2/.
