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Dr. Sachs retires from FDA, leaving mark on pediatric drug development :

March 10, 2020

Throughout her career at the Food and Drug Administration (FDA), Hari C. Sachs, M.D., FAAP, was involved in adding pediatric labeling information to hundreds of drugs and biological products as well as in efforts to improve labeling for drugs used during lactation.

All the while, she continued caring for children in outpatient pediatric practice, which enabled her to provide clinical expertise and perspective to new regulatory efforts.

Dr. Sachs retiredin late February after 18 years at the FDA.

“As a member of the AAP and FDA liaison to the AAP Committee on Drugs, Dr. Sachs’ dedication to the health and welfare of all children has been evidenced during her many years advocating for safe and effective drugs for children. The American Academy of Pediatrics is grateful for her contributions to pediatric therapeutics,” said AAP CEO/Executive Vice President Mark Del Monte, J.D.

Dr. Sachs graduated from the University of Maryland School of Medicine and completed her residency training at Children’s National Medical Center in Washington, D.C. After 14 years in pediatric practice, Dr. Sachs joined the FDA in 2002, at a time of significant progress in pediatric drug development. She advocated for studying drugs in all age groups that could benefit, while guarding the safety of children involved in research.

“Dr. Sachs has been key to FDA’s successful implementation of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act,” Del Monte said.

Dr. Sachs received numerous awards at the FDA and was named as a Washingtonian Top Doctor. She created the Diligence and Outstanding effort Leveraging Pediatric and maternal health with Hard work and INnovation (DOLPHIN) award to encourage her mentees.

Dr. Sachs’ tireless enthusiasm and positive leadership style will be greatly missed.

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