Captain Kendra Stewart closes generic drug forum, urges higher‑quality ANDA submissions

Captain Kendra Stewart, director of the Office of Regulatory Operations for the Office of Generic Drugs, closed the two‑day generic drug forum with a brief address thanking attendees for their participation and engagement. She said the forum’s primary objective was “to gain practical regulatory knowledge and to enhance … ANDA applications, streamline the assessment process, and ultimately reduce review cycles.”

Stewart framed the work as a public‑health collaboration that helps ensure patients have timely access to safe, high‑quality generic medicines. She urged applicants to submit high‑quality files and said the Office remains focused on modernizing processes and enhancing efficiency to foster innovation in generic drug development and approval. “Together, we can further improve the generic drug development process, addressing emerging challenges, and ensuring that American patients have access to the medicines they need,” she said.

Stewart also called attention to resources highlighted earlier in the forum by OGD deputy Darby Kozak: an on‑demand resource page with webinars and presentations aimed at reducing common application deficiencies. She said a QR code linking to the event page—where presentations will be housed—would be available at the close of the forum.

In closing remarks Stewart repeated commonly cited metrics on the scale and value of generics, saying they make up more than 90% of prescriptions filled in the U.S. and save Americans more than $1,000,000,000 a day. She thanked participants again and wished them safe travels.