Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

In June, the FDA published a "Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products". This document was created to provide 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 recombinant viral or microbial products (GTVVs).

Scope of this guideline is to describe what to consider when a sponsor is determining whether he is required to submit an EA for his IND, BLA, or BLA supplement for a GTVV, or whether his submission qualifies for categorical exclusion under 21 CFR 25.31.  Additionally, for those INDs, BLAs, or BLA supplements for GTVVs for which an EA is required, this guidance provides information on the content and format of the EA submission.

The need of such an evaluation based on the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. § 4321, et. seq.) requires all federal agencies to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed of the environmental analyses.

The complete draft can be found here.