The FDA has released draft guidance that lays out the process that sponsors must follow for priority review of generic drugs that are in short supply, are sole-source or first-in-class generics, or could help alleviate public health emergencies.​

Under Generic Drug User Fee Amendments (GDUFA II), the FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or amendment.

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