Introduction and consideration of FDA's"Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products:Nonclinical Information Guidance for Industry"
Food and Drug Administration(FDA)issued a draft guidance which entitled"Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products:Nonclinical Information Guidance for Industry"at May 2023.It is designed to assist sponsors determining whether it is appropriate to rely on generally accepted scientific knowledge(GASK)to meet the approval requirements for New Drug Application(NDA)or Biologics Licensing Application(BLA).The guidance described two circumstances in which applicants can rely on GASK to support drug approval without conducting certain non-clinical studies.The guidance can simplify the research and evaluation of the related new products,and accelerate the approval of new drugs or biologics,and it is expected that the relevant principles will be helpful for the research and regulation of the related new products in China.
Food and Drug Administrationgenerally accepted scientific knowledgeNew Drug ApplicationBiologics Licensing Applicationguidance
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