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​Newsletter - March 4, 2021

Too Many Poorly Designed Trials Led to the Lag in Covid Therapeutics: FDA

In the last 12 months, more than two thousand Phase 2 and 3 clinical trials were launched worldwide to evaluate various therapeutics for COVID-19, containing 2895 individual treatment arms aiming to recruit more than 500,000 patients. However, an FDA analysis showed that only 5% of these trials...Read More
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FDA “Requests” Fraudsters to Stop Making Fake Certificates

FDA released a strange email “request” today to firms issuing misleading “FDA Registration Certificates” that look like government documents and include FDA’s logo. FDA is aware that such certificates, which are very common for Class I medical devices, are used to deceive consumers to think a device...Read More

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