Regulacje i polityka gospodarcza · 21/12/2007

FDA Amends Virus-Serum-Toxin Act Regulations for Live Vaccines

The US Food and Drug Administration (FDA) has updated the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the need for retesting Master Seeds for immunogenicity 3 years after the initial qualifying test, and also eliminating mouse safety tests for biological products intended for animals other than poultry.