FDA finalizes Guidance on 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In June 2014, the FDA published a "Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or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).

Now the authority finalized this document and published the adopted guidance with the same name. 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.

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.

For more details, read the complete Guidance for Industry "Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products".