By Dr Nicola Davies
According to US Food and Drug Administration regulations, the regulatory agency may refuse to file a new drug application (NDA) or biologics license application (BLA) when either is deemed incomplete, writes Dr Nicola Davies in her monthly blog for The Pharma Letter.
Such refuse-to-file (RTF) actions are regulatory tools to prevent multiple-cycle reviews of deficient applications, which can be time-consuming, costly, and unnecessary.1
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