A Review on New Drug Application (NDA) and General Consideration in Pharmaceutical Industry

[摘要] In the pharmaceutical industry the course is designed to give you the skills that have taken many experienced The New Drug Application (NDA) is an application submitted to U.S.FDA for permission to market a new drug product in the United States. The New Drug Application (NDA) is an application submitted to U.S.FDA for permission to market a new drug product in the United States. The components of any NDA are a function of the nature of the subject drug and the information available to the applicant at the time of submission. The form to use for either NDA or ANDA is Form FDA-356h, Application to Market a New Drug for Human Use or as an Antibiotic Drug for Human Use. The international regulatory authorities under consideration are WHO, USFDA, MHRA, and Australian TGA. The standard institutions give the economical background for development and transferring technologies, ISI, ISO, BISS and ASTM. To legally gather this data on safety and effectiveness in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA.

[学科分类] 药学

[关键词] Regulatory authority;ANDA;NDA;IND.