Due to safety and effectiveness concerns, the US FDA has postponed the review of two drugs in its new application plan.
Internal documents seen by the media show that the US Food and Drug Administration has delayed the review of two drugs selected for the Trump administration's new fast-track program because the agency's scientists raised concerns about their safety and effectiveness, including a patient's death while taking one of the drugs. FDA reviewers have delayed the review of an experimental drug by Disc Medicine for treating a rare blood disorder by two weeks because of concerns about the trial data and its potential for misuse. They also postponed the review of Tzield, a drug by French pharmaceutical company Sanofi for treating late-stage type 1 diabetes, for over a month due to adverse event reports, including two adverse events related to seizures and blood clotting and one death event.
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