FDA Issues Guidance on Environmental Assessments
The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.
FDA has issued a final guidance document for sponsors of investigational new drug (IND) applications and biologic license applications (BLA) recommending considerations for determining whether to submit an environmental assessment (EA) for gene therapies, vectored vaccines, and related viral or microbial products. The agency also details what information should be included in an EA.
The guidance includes EA considerations for INDs, BLAs, and BLA supplements for gene therapies and vectored vaccines for infectious disease indications. It also includes EA considerations for INDs, BLAs, and BLA supplements for related viruses and microbes that were generated using recombinant DNA technology. According to the guidance, “EA considerations for INDs, BLAs, and BLA supplements for live attenuated viral or microbial vaccines created by traditional methods, such as serial passaging and recombinant protein-based vaccines,” are not addressed.
Source: FDA.gov
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
