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FDA ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA

蒋千琴 10/14/2021 浏览 102 FDA United States

标准简介

ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA[附网盘链接]是Food&Drug Administration于之前发布的FDA标准，适用于United States。

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ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA[附网盘链接]
ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA[附网盘链接](截图)

 

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标准部分原文

ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to explain to applicants 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) submitted to the Food and Drug Administration under section 505(j) of the Federal Food, Drug, 2

and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an 3

application’s review goal dates. The guidance also describes how FDA should assess amendments submitted to ANDAs and PASs received prior to October 1, 2017, which is the GDUFA II review goals effective date. This guidance finalizes the October 2017 draft guidance for industry ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA. This final guidance supersedes the December 2001 guidance for industry Major, Minor, and Telephone Amendments 1

This guidance has been prepared by the Office of Generic Drugs in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

Although not directly within the scope of this guidance, we remind applicants of the patent certification requirements applicable to ANDA amendments in 21 CFR 314.96(d)(1). See also 81 FR 69580, 69591-96, and 69636-39 (October 6, 2016). 3

To reinforce the policy and procedural changes set forth in the Manual of Policies and Procedures (MAPP) 5241.3 Good Abbreviated New Drug Application Assessment Practices, the Office of Generic Drugs and the Office of Pharmaceutical Quality will use the term assessment in place of review. MAPP 5241.3, available on the Manual of Policies and Procedures (CDER) web page at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProc

edures/default.htm, defines assessment as “the process of both evaluating and analyzing submitted data and information to determine whether the application meets the requirements for approval and documenting that determination.” MAPP 5241.3 at 3.

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