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
What Is Case Report Form Case Report Form is a specialized tool in clinical research for collecting all data from each participating subject or patient in a clinical trial. The sponsor usually develops or outsources CRF development to collect the specific data they need to…Seguir leyendo
