FDA Development of a Shared System REMS Guidance for Industry

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Draft — Not for Implementation 1 Development of a Shared System REMS 1

2 Guidance for Industry 3 4 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 5 Administration (FDA or Agency) on this topic.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

16 evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) 3

17 products. This guidance describes some of the possible benefits of a shared system REMS, and 18 provides general principles and recommendations to assist industry with the development of 19 these programs. This guidance does not discuss the process for requesting a waiver of the single, 20 shared system REMS requirement that applies to abbreviated new drug applications (ANDAs) 4

21 referencing a listed drug with an approved REMS. FDA issued a separate guidance describing 5

22 the process for requesting waivers and the criteria FDA applies in considering them. 23 24 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 25 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 26 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 1

This guidance has been prepared by the Office of Surveillance and Epidemiology, Office of New Drugs, Office of Generic Drugs, and Office of Regulatory Policy in the Center for Drug Evaluation and Research (CDER), in cooperation with the Center for Biologics Evaluation and Research (CBER), at the Food and Drug Administration. 2

A shared system REMS encompasses multiple prescription drug products and is developed and implemented jointly by two or more applicants. 3

For purposes of this guidance, unless otherwise specified, references to “drugs” and “drug products” include prescription drugs submitted for approval or approved under section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b) or (j)) and biological products submitted for licensure or licensed under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), other than biological products that also meet the definition of a device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). 4

See section 505-l(i)(l)(B) of the FD&C Act (21 U.S.C. 355-1(i)(1)(B)). 5

See the draft guidance for industry Waivers of the Single, Shared System REMS Requirement. We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page (available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm) or Biologics guidance web page (available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm). When final, this guidance will represent FDA’s current thinking on this topic. 1

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