Warning Letter Close-Outs – May 2022
The US FDA released three close-out letters last month, publicly resolving warning letters issued to companies based in Germany, Sweden, and Seattle, WA.
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A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion
The US FDA appears poised to release long-promised regulations on lab-developed tests. However, some industry observers still have doubts as to whether the agency is truly prepared.
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