FDA Guidance expands environmental perspective

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The FDA is tweaking its environmental impact guidance. Regulatory Focus reports that while required Environmental Assessments have been around for drugs since it issued its 1998 draft guidance, the guidance is a little dated in that it does not cover genetic therapy / biotech treatments.

RF notes that the new guidance, named Determining the Need for and Content of Environmental Assessments for Gene  Therapies, Vectored Vaccines and Related Recombinant Viral or Microbial Products “is meant to change that.”

These rules apply to items that require Biologics License Applications, known as BLAs, which accompany treatments submitted for FDA review.

RF notes the Food and Drug Administration is asking BLA-submitting drugmakers to include information such as descriptions of the substance and byproducts “that might find their way into the environment,” and “what effects could transgene expression or exposure have outside of the target populations?”

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