FDA Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry

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Completeness Assessments for Type II API DMFs Under GDUFA

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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 for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions). The guidance explains that, as of October 1, 2012, under the Generic Drug User Fee Amendments of 2012, commonly referred to as 2 GDUFA:  DMF holders are required to pay a DMF fee when first authorizing the reference of their 3 DMF in a generic application  Type II API DMFs must undergo an FDA completeness assessment (CA) The guidance makes recommendations about the information that should be included in the DMF to facilitate a GDUFA CA. The guidance does not apply to Type II API DMFs used to support 4

new drug applications (NDAs), biologics license applications (BLAs), other submissions that 5 are not generic drug submissions, or any other types of DMFs. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1

This guidance has been prepared by the Center for Drug Evaluation and Research and the Center for Biologics

Evaluation and Research at the Food and Drug Administration. 2

Public Law 112-144, Title III.

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For these purposes, such authorization is deemed to have occurred when the DMF “is referenced on or after

October 1, 2012, in a generic drug submission by an initial letter of authorization,” Section 744B(a)(2)(A) of the

Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379j-42(a)(2)(A).

4 Type II API, API intermediate, and drug product DMFs are not used to support BLAs submitted pursuant to

sections 351(a) and 351(k) of the Public Health Service Act (42 U.S.C. 262).

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See section 744 A(7) of the FD&C Act (21 U .S.C. 379j-41(7)).

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