Unsuitable endpoints and poor dosage selection behind rejections at US FDA
This article was originally published in SRA
While some rejections or delays by the US Food and Drug Administration 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 the 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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