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FDA Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

蒋千琴 2/12/2022 浏览 294 FDA US

标准简介

Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products[附网盘链接]由Food And Drug Administration于过去发布，适用于US。

标准截图

Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products[附网盘链接]
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products[附网盘链接](截图)

 

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标准部分原文

Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines and Related Recombinant Viral or Microbial Products ______________________________________________________________________________ Guidance for Industry This guidance represents the Food and Drug Administration’s (FDA’s or Agency’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 using the contact information on the title page of this guidance. I. INTRODUCTION We, FDA, are issuing this guidance to provide you, investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA) or a supplement to a BLA (BLA supplement), with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related 1

recombinant viral or microbial products (GTVVs). This guidance also contains recommendations as to what information should be included in an EA and what you can expect once an EA is filed. This guidance finalizes the draft guidance of the same title dated June 2014. This guidance also supplements the guidance entitled “Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications” dated July 1998, (July 27, 1998, 63 FR 40127) (1998 Guidance) and supersedes the recommendations for GTVVs in section IV.B.1 “Assessing Toxicity to Environmental Organisms” in the 1998 Guidance. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’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 FDA’s guidances means that something is suggested or recommended, but not required. 1

This guidance has been prepared by the Office of Cellular, Tissue and Gene Therapies (OCTGT) in FDA’s Center for Biologics Evaluation and Research (CBER) in consultation with the Office of Vaccines Research and Review (OVRR), CBER. Both OCTGT and OVRR review the IND submissions and BLA applications or supplements for GTVVs.

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