Reviewer Diagram Project

Reviewer Diagram Project

The goal of FDA’s Good Review Practices (GRP) Track II is to design a flexible, evolving and interactive review process that focuses on development and improvement. The Reviewer Diagram Project*, under the auspices of GRP Track II, has the following objectives:

• to dissect individual review processes and create diagrams.
• to allow reviewers and supervisors to record and visualize the steps in their own review process.
• to communicate an understanding of the framework, content, process and issues involved in review activity.
• to create a final, customizable plan and diagram for each therapeutic area.

Review diagrams for this project were produced from a written outline or from an interview with an individual medical officer; the diagrams were edited by colleagues from the same division. The diagrams represent attempts by individual medical officers to visualize their own review processes; they do not represent official CDER or division standards. They are offered for display on this Web page in the spirit of transparency. It is hoped that access to process diagrams from individual reviewers will be helpful to the public and the pharmaceutical industry.

Five diagrams created by individual medical reviewers from four divisions in CDER can be accessed from this page.  Other diagrams may be added in the future.    Diagrams were created using Micrografx Flowcharter, then published and linked with Adobe Acrobat Exchange.  Shaded boxes in the diagrams represent hyperlinks to other pages in the diagram.

The CDER divisions and the authors of the diagrams are:

• Division of Anti-Infective Drug Products (Nasim Moledina)
• Division of Antiviral Drug Products (Stanka Kukich)
• Division of Neuropharmacological Drug Products (Greg Dubitsky)
• Division of Oncology Drug Products (Susan Honig)
• Division of Oncology Drug Products (Grant Williams)

*Members of the Review Diagram Project steering committee included Madeline VanHoose (project facilitator), Grant Williams (project leader), Brad Leissa, Joy Mele, David Lepay, Janet Woodcock, Nancy Smith, and Julie Carlston. Diagrams were constructed by Madeline VanHoose and edited by reviewers.

Questions or Comments? Email: williamsg@cder.fda.gov

FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DML
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