The Food and Drug Administration (FDA) has released draft guidance for industry titled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This guidance, once finalized, will explain the FDA's approach to using Type VII Veterinary Master Files, which are useful for research involving animal cells, tissues, gene therapies, and certain genetic alterations. The guidance aims to facilitate confidential information exchange with FDA and promote communication during early product development. Comments on the draft can be submitted electronically or by mail by March 10, 2025, to ensure consideration before finalization.
Simple Explanation
The FDA is sharing new rules for looking at and testing animal medicines and gene changes, so companies can share special information safely and talk with the FDA when they start making new animal products. You can tell the FDA what you think about these rules until March 10, 2025.