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A Strategic Approach: Best Practices for Commenting on Draft FDA Guidance Documents for Drug and Device Companies

Thursday, June 6, 2024
10:45 AM – 11:45 AM EDT
Location: Concourse B
This session aims to provide the attendees from drug and medical device companies understand the best strategies for effectively commenting on draft FDA guidance documents. The participants will understand the process, best practices with examples, monitoring comments' status, and the benefits of collaborative commenting through trade associations.

Learning Objectives:

  • Upon completion of this session, participants will be able to understand the best practices for effectively commenting on draft FDA guidance documents.
  • Upon completion of this session, participants will be able to understand the importance and process of commenting on draft FDA guidance documents.
  • Upon completion of this session, participants will be able to understand the benefits of submitting comments through trade associations.