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FDA Finalizes Guidance on GDUFA II

Posted 03 July 2018 | By Zachary Brennan 

FDA Finalizes Guidance on GDUFA II

The US Food and Drug Administration (FDA) on Tuesday finalized guidance to help sponsors understand how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs).

The 32-page final guidance contains clarifications to the draft guidance of the same title that published in October 2017, the agency said.

Simplification

The GDUFA II Commitment Letter includes changes in the classification of and review goals for amendments to ANDAs and PASs under GDUFA I, when amendments were classified into a Tier-based system based on: “whether the amendment was solicited (i.e., submitted in response to a complete response letter (CRL)) or unsolicited (i.e., submitted on the applicant’s own initiative); whether the amendment was major or minor (as defined in the guidance for industry ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA); the number of amendments submitted to the ANDA or PAS; and whether an inspection was necessary to support the information contained in the amendment.”

GDUFA II, meanwhile, simplified the amendment review goals and no longer subjects them to a Tier-based system; however, GDUFA II review goals are still dependent on several factors, as described in section IV of this final guidance.

Under that section, FDA said it will review and act on 90% of standard major ANDA amendments within eight months of the amendment submission date if FDA does not require a preapproval inspection. If an inspection is necessary, the timeline shifts to 10 months.

As far as priority major ANDA amendments, FDA said it will review and act on 90% within six months of the amendment submission date if preapproval inspection is not required. But that timeline moves to eight or even ten months depending on certain circumstances.

FDA also said it will review and act on 90% of standard and priority minor ANDA amendments within three months of the amendment submission date, and 90% of standard major PAS amendments within six months of the amendment submission date if preapproval inspection is not required, otherwise within 10 months. For priority major PAS amendments, FDA said it will review and act on 90% within four months of the amendment submission date if preapproval inspection is not required.

Other goal dates are further explained in the final guidance, and appendices also include information on major deficiencies and guidance for industry on major, minor and telephone amendments to ANDAs.

ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry
 

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