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FDA Competitive Generic Therapies

蒋千琴 12/15/2021 浏览 146 FDA 美国

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Competitive Generic Therapies[附网盘链接]由FDA于之前发布，适用于美国。

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Competitive Generic Therapies[附网盘链接]
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Competitive Generic Therapies 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 2

The FDA Reauthorization Act of 2017, or FDARA, created a new pathway by which FDA may, 3 4

at the request of the applicant, designate a drug with “inadequate generic competition” as a 5

competitive generic therapy (CGT). At the request of the applicant, FDA may also expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT. 6 7

This guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs. Finally, it provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. 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 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

Public Law 115-52. 3

For the purposes of this guidance, the term drug is intended to cover any product submitted for approval in an ANDA, including those products meeting the definition of a combination product under 21 CFR 3.2. 4

See section 506H(b)(3), (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356h(b)(3), (e)(2)). 5

The term generic drug refers to a drug that is approved pursuant to section 505(j) of the FD&C Act (21 U.S.C. 355(j)). See section 506H(e)(1). 6

This guidance has been issued in accordance with section 803(b)(1) of FDARA. 7

For the purposes of this guidance, the term applicant refers to any person developing a drug intended for submission in an ANDA or any person who submits a drug in an original ANDA.

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