FDA ANDA Submissions - Refuse-to-Receive Standards Questions and Answers Guidance for Industry

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Draft — Not for Implementation 1 ANDA Submissions – Refuse-to-Receive Standards: 2 Questions and Answers 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 15 I. INTRODUCTION 16 17 This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new 2

18 drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs. This 19 guidance provides answers to questions we have received from applicants regarding the guidance 3

20 for industry, ANDA Submissions—Refuse-to-Receive Standards (RTR Standards guidance) and 21 the filing review process, in general. The questions and answers address general issues about the 22 organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related 23 to Drug Master Files (DMFs), product quality, and bioequivalence (BE) and clinical reviews, and 24 are intended to clarify the deficiencies that may cause FDA to refuse to receive (RTR) an 25 ANDA. An RTR decision indicates that FDA has determined that an ANDA is not a 26 substantially complete application (i.e., that the ANDA, on its face, is not sufficiently complete 4

27 to permit a substantive review). 28 29 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 30 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 31 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 1

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

For purposes of this guidance, the use of the term ANDA will mean ANDAs and PAS submissions to ANDAs, as described in the introduction. 3

The RTR Standards final guidance was issued in September 2014 (see Guidance for Industry on [ANDA] Submissions—Refuse-to-Receive Standards; Availability, 79 FR 55813, September 17, 2014). A revised final guidance was posted to FDA’s web site on May 26, 2015, which contained minor changes to clarify text, improve readability, and reference the Office of Pharmaceutical Quality, which was established after the original guidance posted in September 2014. A subsequent revised final version was posted to FDA’s website on December 21, 2016. This most recent revised guidance contains further clarifications of policy and minor changes in policy to benefit applicants. 4

21 CFR 314.101(b)(1) and 314.3(b).

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