19 June 2017 - In preparation of its commitments under the second Generic Drug User Fee Amendments, the US FDA on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.

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

"This critical 2-month lead time provides the agency the opportunity to determine whether facility inspections will be needed, and, when they are, to initiate inspection planning earlier in the review of the ANDA, enabling FDA to meet the shorter review timeframe," FDA writes.

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