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
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
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
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
