The FDA recently released an online course to provide insights to drug sponsors on communicating with the FDA during drug development. The hour-long course, Best Practices for Communication Between FDA and IND Sponsors During Drug Development, is designed to describe the best practices and procedures for timely, transparent, and effective communications between IND sponsors and FDA at critical junctures in drug development.
After completing the course, IND sponsors are expected to have a greater understanding of FDA’s philosophy regarding timely interactive communication with IND sponsors, the scope of appropriate interactions between the FDA review team and IND sponsors, the appropriate types of advice for sponsors to seek from FDA in pursuing their drug development program, FDA’s general expectation for the timing of their response to IND sponsor inquiries, and the best practices and communication methods for facilitating interactions between the FDA review team and IND sponsors during drug development.
The course is divided into 7 lessons:
- Lesson 1: Background
- Background on PDUFA V commitment to establish Enhanced Communications Team and overview of draft guidance for best practices for communication during drug development
- Lesson 2: Communicating with the FDA
- Overview of sponsors’ and FDA’s primary IND responsibilities, and general FDA goals
- Lesson 3: FDA-Sponsor Interactions During Drug Development
- Summary of the Regulatory Project Manager (RPM) role and responsibilities, a description of the various other CDER project managers, a description of the process by which direct communication should be followed, a description of the role independent consultants play, and tips on developing an informal communication strategy
- Lesson 4: Guidelines for Seeking Advice from FDA
- Steps and guidelines in seeking advice from the FDA dependent on the type and complexity of the question
- Lesson 5: Timelines, Acknowledgements, and Resources
- Acknowledgement that the FDA strives to respond to sponsor all questions promptly, but some inquiries must be prioritized, and consideration that sometimes a clarification question may need a more in-depth response. Also, a clarification on the FDA acknowledgement process with regard to answering queries by sponsors (and vice versa), as well as the resolution pathway for delayed responses, and a description of the Enhanced Communications Team
- Lesson 6: Best Practices and Communication Methods
- Provides best practices and communications methods for a variety of situations, including meetings between FDA and sponsors, written correspondence, email, general phone calls, faxes, and more
- Lesson 7: Resources and Contacts
- Description of the various outlets the FDA uses to disseminate information, including web sites, portals, social media, and interactive media, and also provides a list of helpful FDA contact email addresses
The course can be accessed here.