FDA Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

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Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。

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Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act 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 provides information regarding FDA’s current thinking on interpreting section 505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(q)). Section 2

505(q) of the FD&C Act governs certain citizen petitions and petitions for stay of Agency action that request that FDA take any form of action related to a pending application described in 3

section 505(b)(2) or 505(j) of the FD&C Act or a pending application described in section 4

351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). This guidance describes FDA’s interpretation of section 505(q) regarding how the Agency determines if (1) the provisions of section 505(q) addressing the treatment of citizen petitions and petitions for stay of Agency action (collectively, petitions) apply to a particular petition and (2) a petition would delay approval of a pending abbreviated new drug application (ANDA), 505(b)(2) application, or 351(k) application. This guidance also describes how FDA interprets the provisions of section 505(q) requiring that (1) a petition include a certification and (2) supplemental information or comments on a petition include a verification. It also addresses the relationship between the review of petitions and pending ANDAs, 505(b)(2) applications, and 351(k) applications for which the Agency has not yet made a decision on approvability. This guidance revises and supersedes the guidance for industry Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act issued 1

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

For brevity, in this guidance, references to section 505(q) of the FD&C Act are cited as section 505(q). 3

In this guidance, an application described in section 505(b)(2) of the FD&C Act is referred to as a 505(b)(2) application and an application submitted under section 505(j) of the FD&C Act is referred to as an abbreviated new drug application (ANDA). 4

In this guidance, an application submitted under section 351(k) of the PHS Act is referred to as a 351(k) application. 1

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