FDA ANDAs Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence)

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ANDAs Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence)[附网盘链接]是Food&Drug Administration于过去发布的FDA标准，适用于US。

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Draft — Not for Implementation 1 ANDAs: Pre-Submission of Facility Information Related to 2 Prioritized Generic Drug Applications (Pre-Submission Facility 3 Correspondence) 1,2

4 Guidance for Industry 5 6 7 This revised draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 I. INTRODUCTION 15 3

16 The Food and Drug Administration (FDA) is issuing this revised draft guidance to describe the 4

17 process through which prospective generic drug applicants seeking a priority review goal 18 submit complete, accurate facility information in advance of submitting a priority original 19 abbreviated new drug application (original ANDA), prior approval supplement (PAS), PAS 5

20 amendment, or ANDA amendment (hereafter collectively referred to as ANDA). FDA is 21 revising the draft guidance because, after issuance of the original draft guidance, section 22 505(j)(11) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (U.S.C. 355(j)(11)) as 6

23 added by section 801 of the FDA Reauthorization Act of 2017 (FDARA) resulted in changes to 24 the pre-submission of facility information. Specifically, that provision requires the pre-

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25 submission of relevant sections of the ANDA as determined by FDA. This permits FDA to 26 utilize the existing process for submission of ANDAs (including electronic Common Technical 1

This guidance has been prepared by a multidisciplinary workgroup including members from the Office of Pharmaceutical Quality, the Office of Translational Sciences, the Office of Generic Drugs, and the Office of Business Informatics in the Center for Drug Evaluation and Research at the Food and Drug Administration, and in consultation with the Office of Regulatory Affairs, the Office of Combination Products, and the Center for Devices and Radiological Health. 2

When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 3

The first draft of this document, ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions, was issued pursuant to 21 CFR 10.115 in June 2017. See Federal Register notice at 82 FR 28072. 4

In this guidance, italicized text is used to denote terms that are defined in section IX, Definitions. 5

In this guidance, the term "ANDA" collectively includes original ANDAs, PASs, PAS amendments, and ANDA amendments. The term "original ANDA" is used alone when referring exclusively to an original abbreviated new drug application. 6

Public Law 115-52. 7

Section 505(j)(11) also makes clear that the pre-submission of facility information is not the submission of an original ANDA under Section 505. That is important because the submission of an original ANDA is delayed by statute until 5 years after approval of the reference listed drug (or 4 years if there is a patent challenge) in certain circumstances, see Section 505(j)(5)(F)(ii), and the statute makes clear that the pre-submission can be submitted before the date that a full original ANDA can be submitted.

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