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Legal & RegulatoryEvent: September 3, 2026

FDA is adding resources and expanding foreign BIMO inspections, including early-phase and Phase 1 trials, to scale with global science and risk.

Published

Signal category

Legal & Regulatory

Quote

We are adding resources and expanding foreign BIMO inspections — including early-phase and Phase 1 trials — because risk doesn't wait for Phase 3.

Lowell M. Zeta|FDA team

Company

Industry
Government Administration
Location
Silver Spring, US
Company size
17,774 employees

The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

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