FDA ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

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ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin[附网盘链接]由Food&Drug Administration于之前发布，适用于U.S。

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ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin 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 staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin (peptide of rDNA origin) should be submitted as an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new drug application (NDA) 2

under section 505(b) of the FD&C Act. Specifically, this guidance provides recommendations for evaluating whether an ANDA submission is appropriate for a synthetic peptide that references any of the following five previously approved peptide drug products of rDNA origin: 3

glucagon, liraglutide, nesiritide, teriparatide, and teduglutide. Given the current state of technology for peptide synthesis and characterization, FDA believes it is now possible for an ANDA applicant to demonstrate that the active ingredient in a proposed 1

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

This guidance does not address ANDAs for peptides of rDNA origin. Based on the types of data permitted to be submitted in an ANDA (see section 505(j)(2)(A) of the FD&C Act) and current scientific considerations, FDA does not expect that an ANDA could include sufficient evidence (e.g., clinical investigations to assess potential immunogenicity) for approval of a proposed peptide of rDNA origin at this time. An applicant seeking approval of a proposed peptide of rDNA origin may file a 505(b)(2) application or a “stand-alone” NDA submitted under section 505(b)(1) of the FD&C Act. 3

This guidance does not address all studies and information that should be submitted in support of an ANDA for a synthetic peptide. Applicants should check on the availability of other guidances, including product-specific guidances, for such recommendations. Guidances relating to generic drugs can be found at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs. Product-specific guidances for generic drug development can be found athttps://www.fda.gov/drugs/guidances-drugs/product-

specific-guidances-generic-drug-development. Also, a potential applicant may request information on a specific element of generic drug development via controlled correspondence or, for complex products such as peptides, may submit a request for a Pre-ANDA meeting. 1

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