Drug Development Process – From Discovery to Marketing

Overview: This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. We will begin by reviewing the contents of an Investigational New Drug (IND) application, and then follow the process of an IND submission. Next, the contents and approval process of an NDA submission will be discussed. […]

Master regulatory files

Master regulatory files are a set of documents the manufacturer of a drug or medical device has to furnish to the FDA. A Drug Master File (DMF) is a prime example of a kind of master regulatory files. Master regulatory files are provided to the regulatory authority to provide confidential information about the product, such […]