Submissions to FDA must have sufficient detail so FDA reviewers can understand and duplicate your key data analyses.

Because I understand how reviewers think and work, I can create reviewer friendly submissions that will anticipate and answer reviewer’s questions and issues. The result is faster approval time.

“Good Review Management: FDA’s Internal Standards and Expectations of Industry”

“Implementing FDA’s 2008 Guidance on the Integrated Summary of Effectiveness (ISE)”

“Survey of FDA Reviewer Training: Understanding Reviewer Strategies, Tools and Techniques”

⁽¹⁾ Contact me and the table of contents from any class can be emailed to you