抄録
In February 2006, the FDA released its guidance to industry on the non-clinical safety evaluation of pediatric drug products. The draft guidance was first issued in February 2003. Since the issuance of the draft guidance in 2003, there has been a great deal of activity within the scientific community in both the US and Europe to understand the need for and conduct of the appropriate studies. Late in 2005, the EMEA issued a draft guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for pediatric indications. The presentation will compare and contrast the FDA and EMEA guidance’s. In addition, the responses in the US to the EMEA draft guideline will be highlighted. Overall, while differences exist in the two documents, a single study should suffice to address the intent of both regulatory bodies. An unanswered question is how each regulatory agency will interpret the need for a non-clinical juvenile animal study. Additionally, the presentation will cover approaches to address the requirements set forth by the FDA and EMEA. The presentation will conclude with a request to Japan as they begin to evaluate their needs in the area of non-clinical juvenile animal studies.
