License requirements for recombinant DNA veterinary biologics in U.S.A.
The USDA license requirements for present and future veterinary biologics remain essentially unchanged for acceptable rationale and biostatistically significant data establishing consistency of satisfactory production, purity, safety, efficacy and potency. The current requirements, developments, adaptations, additions and deletions are discussed.
D000818:Animals; D001688:Biological Products / Q000592:standards*; D003264:Containment of Biohazards; D004274:DNA, Recombinant; D008004:Licensure; D014481:United States; D014730:Veterinary Medicine
D001688:Biological Products; D004274:DNA, Recombinant