New guidance: When can the FDA refuse to file NDAs and BLAs?

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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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