Zdrowie i gospodarka · 24/06/2024

FDA Releases Draft Guidance for Industry on Chemistry, Manufacturing, and Controls for Recombinant Protein Products for Veterinary Medicinal Use

The FDA has released a draft guidance for industry (GFI #288) outlining the required information for Chemistry, Manufacturing, and Controls (CMC) submissions related to recombinant protein products for veterinary medicinal use. This guidance addresses the unique characteristics of recombinant protein production and differs from other FDA guidances for synthetic chemical substances.