FDA CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM

标准简介

CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM[附网盘链接]由Food&Drug Administration于当前发布，适用于美国。

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DISPUTE RESOLUTION PROCEDURES FOR SCIENCE-BASED DECISIONS ON PRODUCTS REGULATED BY THE CENTER FOR VETERINARY MEDICINE (CVM) This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION This guidance document describes a recommended approach for resolution of disputes relating to scientific controversies. A scientific controversy involves issues that arise within the context of the Center’s regulation of a specific product and are related to matters of technical expertise that require some specialized education, training, or experience in order to be understood and resolved. The guidance document describes the dispute resolution procedures that we recommend be followed by sponsors, applicants, and manufacturers when requesting review of FDA decisions related to regulated products for animals. (Hereafter in this document, the term applicant includes a sponsor, applicant, or manufacturer.) FDA’s guidance documents, including this guidance, 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 the word should in Agency guidances means that something is suggested or recommended, but not required. II. BACKGROUND On November 21, 1997, the President signed the Food and Drug Modernization Act of 1997 (FDAMA) into law (Public Law 105-115). Section 404 of FDAMA amends the Federal Food, Drug, and Cosmetic Act (the act) by adding a provision (Section 562, 21 U.S.C. § 360bbb-1) for dispute resolution. If a procedure under which an applicant could request a review of a scientific controversy related to human drugs, animal drugs, human biologics, or devices did not already exist, either as a provision in the act or a regulation promulgated under the act, FDAMA required FDA to establish a procedure by regulation through which an applicant may request review of such scientific controversy, including a review by an appropriate scientific advisory panel or advisory committee. Prior to FDAMA, a procedure for review of such controversies was provided under §10.75 (21 CFR 10.75), Internal agency review of decisions. § 10.75 provides for internal agency review of a decision through “the established agency channels of supervision or review.”

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