An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.
Anyone participating with the submittal process must understand how the process is structured and operated in order to bring generic pharmaceuticals and therapeutic products to market properly, successfully, and expeditiously. Furthermore, with the passing of GUFDA II, which drastically alters the fee structure, it is critical to comprehend the program's fundamental changes as well as their implications for the generics market.Areas Covered in the Webinar:
The audience for this webinar would consist of anyone in the generic pharma business in the following functions:
President, C H Paul Consulting Inc
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.
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