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FDA ANDA Submissions -- Refuse-to-Receive Standards Rev.2

蒋千琴 10/13/2021 浏览 263 FDA 美国

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ANDA Submissions -- Refuse-to-Receive Standards Rev.2[附网盘链接]是FDA发布的FDA标准，适用于美国。

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ANDA Submissions -- Refuse-to-Receive Standards Rev.2[附网盘链接]
ANDA Submissions -- Refuse-to-Receive Standards Rev.2[附网盘链接](截图)

 

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ANDA Submissions – Refuse-to-Receive Standards 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 assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the 2

applicant is seeking approval of a new strength of the drug product. The guidance highlights 3

deficiencies that may cause FDA to refuse to receive (RTR) an ANDA. An RTR decision 4

indicates that FDA determined that an ANDA is not substantially complete. A substantially complete ANDA is “an ANDA that on its face is sufficiently complete to permit a substantive 5

review.” This guidance is not meant to be a comprehensive list of the deficiencies that may or will lead to an RTR determination by FDA. Instead, this guidance identifies certain deficiencies and certain recurrent deficiencies that in FDA’s experience have led FDA to RTR an ANDA. This guidance also describes how FDA will assess deficiencies identified during FDA’s filing review to determine whether an ANDA should be received. We note that industry is aware of many of the standards described in this guidance because FDA has historically applied many of these standards in its RTR determinations. FDA’s guidance documents, including this guidance, generally do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. 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

For purposes of this guidance, the use of the term “ANDA” will mean ANDAs and new-strength PAS submissions. 3

An RTR determination should not be confused with a refuse-to-approve determination. 4

21 CFR 314.101(b)(1). 5

21 CFR 314.3(b). 1

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