Federal Register Notice: FDA is making available a document entitled Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry. It provides IND sponsors and applicants for a BLA or a supplement to a BLA 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. The guidance also contains recommendations as to what information should be included in an EA and what you can expect once an EA is filed. It finalizes a 6/2014 draft guidance of the same title. To download this guidance, click here. To view this notice, click here.