TAG: New Drug Application

FDA: Frequently Asked Questions

Raina Rahul Agarwal 30 May, 2022 Clinical Research No Comments
FDA

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…Read more

NDA: New Drug Application & Its Contents

Raina Rahul Agarwal 26 May, 2022 Clinical Research 1 Comment
New Drug Application

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…Read more

Investigational New Drug Application (IND)

Raina Rahul Agarwal 24 May, 2022 Clinical Research 1 Comment
Drug Application

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…Read more