Drug manufacturers constantly strive to successfully sell new drugs to the US Government “Big Four” agencies. This post-conference workshop will explore what drug manufacturers need to know when trying to sell new drugs/drug products. Our speakers will walk you through the application process by using mock scenarios. Points of discussion include:

• Examining the procedure for New Drug Applications (NDA) and understanding why this is important for Big Four contracting
• Where can drug manufacturers look to find this info?
• What is the timeline?
• How should drug manufacturers submit NDAs
• Assessing best practices for compiling and data storage practices
• What kind of substantiation is needed?
• What is considered sufficient data?
• Reviewing the medication needs of “Big Four” agencies
• Does your new product qualify?
• What types of medications are in demand?
• Understanding how to meet new drug qualifications
• Identifying who to contact at the “Big Four” agencies about new drug products:
• VA
• DoD
• Coast Guard
• PHS
• Where can manufacturers go to find this info?
• Is there a specific person or team to reach out to?
• What happens when there is turnover in Government agencies – ow do manufacturers now know who to go speak to?
• Summarizing common reasons that US Government agencies use when declining NDAs
• Understanding how to revise and revamp old rejected applications
• Why was it rejected?
• Examining mock scenarios to highlight key challenges in the application process