This course is designed to help you gain a better understanding of the US drug approval process. You will gain a practical insight into FDA requirements for submission of NDAs, ANDAs and 505(b)(2). It will also cover the organisation and structure of the FDA and review processes, as well as discuss recent changes.
The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs.
Benefits of attending:
This programme will be especially beneficial to those responsible for preparing US registration documents (INDs, NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market.
An overview of the US FDA Drug development regulatory requirements for FDA
Drug development regulatory requirements for FDA (continued)
Overview of the IND application and the data requirements
Maintenance of INDs
Identifying recent changes
Workshop: Understanding FDA meetings
Identifying the NDA types and categories
Review of ANDA/NDA
Understanding ANDA classification
US change control – amendments
Obtaining information from the FDA
Final discussion and review of day