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FDA issues final guidance on ANDA/PAS amendments Posted 31/08/2018

The US Food and Drug Administration (FDA) has issued final guidance outlining the agency’s review goals for amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) under Generic Drug User Fee Amendments II (GDUFA II).

GDUFA provides extra funds for the FDA via the collection of fees from generics’ makers and active pharmaceutical ingredient manufacturers. GDUFA II was signed into law on 18 August 2017 in order to facilitate timely access to quality, affordable generics.

ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA
Date: July 2018
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm404440.pdf

Under the new system, FDA has committed to review and act on 90% of standard major ANDA amendments within 8 months of submission if the agency does not require a pre-approval inspection. In cases where an inspection is necessary, the timeline will be 10 months.

For priority major ANDA amendments, the agency will review and act on 90% within 6 months in cases where pre-approval inspection is not required. In cases where an inspection is necessary, the timeline will be 8 months. The agency has also committed to review and act on 90% of standard and priority minor ANDA amendments within 3 months of submission.

For PAS amendments, FDA will review and act on 90% of standard major PAS amendments within 6 months (no pre-approval inspection) and within 10 months (with pre-approval inspection) of submission. For priority major PAS amendments, the agency will review and act on 90% within 4 months (no pre-approval inspection) and within 8 months (with pre-approval inspection). For standard and priority minor PAS amendments, the FDA will review and act on 90% within 3 months of submission.

The guidance finalizes the October 2017 draft guidance for industry ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA.

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Source: FDA

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