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  1. Drug Safety and Availability

FDA Announces New Quality Oversight Webpage

[03/15/2024] Today, FDA is announcing a new webpage to showcase how the agency uses one of its oversight tools, inspections, to help ensure drug safety and quality.

FDA monitors drugs on the market to help make certain they continue to meet the agency’s standards for safety and quality. All drugs manufactured for the U.S. market, whether manufactured domestically or abroad, must meet the same rigorous quality and safety standards.

“In order to efficiently share relevant information about inspections for human drugs and make it more accessible, FDA is bringing certain data together on a single public webpage,” said Jacqueline Corrigan-Curay, CDER’s principal deputy center director. “Along with manufacturers, we have an important role to help ensure drug safety and quality in a transparent way.”

The page highlights FDA’s oversight of drug quality by providing an overview of the agency’s work to carefully monitor drug manufacturers' compliance with current good manufacturing practice (CGMP) requirements. The page includes information about FDA’s regulatory tools, such as warning letters, and actions following a CGMP inspection. It also links to the FDA data dashboard page with compliance actions.



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