Frequently Asked Questions In Clinical Research Que: What is FDA? Ans: The Full form of the FDA is Food & Drug Administration, which is an agent that is in the USA for the health and human service. The role of the FDA is to ensure…Seguir leyendo
What Is New Drug Application New Drug Application is to obtain approval for marketing and sale of the new drug after the phase-3 clinical trial. It is a request by the sponsor to the FDA. It is a document that provides animal and human studies…Seguir leyendo
What Is Drug Application There are two broad categories of drug applications controlled by the United States Food & Drugs Administration (FDA): Request for authorisation for clinical investigation Request for marketing approval Investigational New Drug Application comes into the first category of drug application, which…Seguir leyendo
