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WASHINGTON — Principal Deputy FDA Commissioner Janet Woodcock will retire early next year from the Food and Drug Administration after helping steer the agency through an historic period of medical advances during nearly four decades in key leadership positions, she confirmed to STAT Thursday.

Woodcock, a doctor with a chemistry degree, joined FDA in 1986 at its biologics center, where she oversaw the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis. In 1994, she was named director of the drug center, where she played a key role in guiding some of the most impactful changes to the regulation of medicine, according to Trump administration FDA Commissioner Scott Gottlieb.

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Woodcock envisioned that antibody drugs would become a backbone of therapy and created a more predictable regulatory path for their review and approval, Gottlieb said. She presided over a major expansion and modernization of the generic drug program, standardizing reviews in a way that allowed the industry to become safer and more robust, and crafted the reform of over-the-counter drug reviews.

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