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Unsuitable endpoints, poor dosage selection lead to FDA rejections, analysis shows

This article was originally published in Scrip

Executive Summary

While some rejections or delays by the FDA of new drug applications (NDAs) or biologic license applications (BLAs) occur because a medicine inadequately performed in clinical testing, some products are not approved because the information submitted to agency is unsatisfactory for regulators to make a determination about whether the drug is safe and effective, according to a new analysis published in the 22 January Journal of the American Medical Association (JAMA).





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