FDA Releases Final ANDA Submission Guidance

• By: Staff Editor
• Date: October 20, 2016
• Source: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404441.pdf

The US Food and Drug Administration (FDA) published a final guidance on October 14, 2016 describing how the Generic Drug User Fee Amendments of 2012 (GDUFA) relates to prior approval supplements (PAS) submissions. The guidance also explains the amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).

What this Guidance Specifies?

Specifically, this guidance defines how the GDUFA performance metric goals apply to:

• A PAS subject to the refuse-to-receive (RTR) standards
• A PAS that requires an inspection
• A PAS for which an inspection is not required
• An amendment to a PAS
• Other PAS-related matters

GDUFA Performance Metric Goals for PAS Submissions

In the Commitment Letter that accompanies the legislation, FDA committed to review and act on a certain percentage of PASs within a specified period from the date of submission for receipts in fiscal year (FY) 2015 through FY 2017. Specifically, FDA agreed to:

• Review and act on 60% of complete PASs that do not require inspection within 6 months from the date of submission for receipts in FY 2015.
• Review and act on 60% of complete PASs that require inspection within 10 months from the date of submission for receipts in FY 2015.
• Review and act on 75% of complete PASs that do not require inspection within 6 months from the date of submission for receipts in FY 2016.
• Review and act on 75% of complete PASs that require inspection within 10 months from the date of submission for receipts in FY 2016.
• Review and act on 90% of complete PASs that do not require inspection within 6 months from the date of submission for receipts in FY 2017.
• Review and act on 90% of complete PASs that require inspection within 10 months from the date of submission for receipts in FY 2017.

Amendments to PAS Submissions

Amendments to PAS submissions are grouped as Tier 1, Tier 2, or Tier 3.

• Tier 1 amendments include the first solicited major amendment, the first five minor amendments, and all delaying amendments. Delaying amendments address actions by a third party that would cause delay or impede application review or approval timing and that were not, or might not have been initially recognized by FDA as, necessary when the application was submitted.
• Tier 2 amendments include all unsolicited amendments not arising from delaying actions as determined by FDA, taking into account the facts and information supplied by the ANDA applicant, excepting those amendments that only remove information from review.
• Tier 3 amendments include any solicited major amendment subsequent to the first major amendment, and any solicited minor amendment subsequent to the fifth minor amendment. There are no GDUFA performance metric goals for Tier 3 amendments.

Relevant Training:

Drug Master Files: New Requirements under GDUFA

http://www.complianceonline.com/drug-master-files-new-requirements-under-gdufa-webinar-training-703209-prdw

eCTD Issues for ANDA Submissions

http://www.complianceonline.com/ectd-issues-for-anda-submissions-15342-prdad