Building Better FDA Submissions
What is a reviewer template? To help reviewers conduct a more consistent product evaluation and write a review report with all required information, FDA created reviewer templates. The template is a detailed outline and explanation of the information that must be in an FDA reviewer's evaluation report.
How can I use this information? Use the template as a checklist to confirm your submission contains all the data and information reviewers need to perform their job. An ideal application is to create a table, which maps the template's requirements to pages in your submission where the information can be found. This information map will also confirm your submission is complete.
Need help implementing these ideas? Contact me. Joshua Sharlin, Ph.D.
Sharlin Consulting
Tel +1-301-570-1107
jsharlin@pipeline.com
www.speedupfda.com
Document Title Pages Check here to Download
1 CDER Clinical Review Template, Manual of Policies and Procedures (MAPP) 40
2 CDER Biostatistics Biologics Licensing Application Template 15
3 CDER Biostatistics New Drug Application Template 15
4 FDA Guidance for Reviewers - Instructions and Template for Chemistry, Manufacturing, and Control 38