FDA Clears Tysabri For Limited Clinical Use
Patients who had previously been receiving the multiple sclerosis therapy are now eligible to participate in Biogen Idec/Elan’s pending safety extension study.
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CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.