This unique course will cover recent trends in FDA approvals, primarily for NMEs, new BLAs, NDA/BLAs, and Efficacy Supplements. It is intended for individuals with experience in the field and an interest in gaining greater insight into current approval trends and what they portend for the future. The course draws on the latest information available from the database analyses, industry surveys, and working group panels that the Tufts Center for the Study of Drug Development (Tufts CSDD) has compiled during its nearly 40 years as an independent, academic research institute within Tufts University Medical School. Your course director will reduce the Tufts CSDD data, as well as, relevant information from consultant and government reports down to the essence of what you need to know about FDA approval trends.
The course will be instructive for professionals and executives working across a broad range of fields in drug and biological product development, but particularly for those in:
- Clinical Development
- Translational Medicine
- Regulatory Science
- Regulatory Affairs
- Risk Management
- Clinical/Regulatory Informatics
- Statistics
- Strategic Planning
- Project Management