Skip over navigation
Banner
Directory
Directory Search
Jobs
Job Search Post a Job
Patient
Patient Resources Drug Development
History
Genealogy
Toons & Teasers
Patient
 Drug Development
 Resources
Quick Links
 Directory
 Job Search
 Toons & Teasers
 Advertising
 
Events
 

EquipNet Auction: Sell Your Surplus Equipment on Our Global Marketplace Now!

Our Newest Cartoon Illustrates: "Milestones in CRISPR"

North American Biotech Roadshow Featuring Grad Students, Post-Docs & Start-Up “Do’s & Don’ts”


Reviews Complete and Acceptable?

The New Drug Development Process.

Much of the primary review process involves reviewer attempts to confirm and validate the sponsor's conclusion that a drug is safe and effective for its proposed use. The review is likely to involve a reanalysis or an extension of the analyses performed by the sponsor and presented in the NDA. For example, the medical reviewer may seek to reanalyze a drug's effectiveness in a particular patient subpopulation not analyzed in the original submission. Similarly, the reviewer may disagree with the sponsor's assessment of evaluable patients and seek to retest effectiveness claims based on the reviewer-defined patient populations.

There is also extensive communication between review team members. If a medical reviewer's reanalysis of clinical data produces results different from those of the sponsor, for example, the reviewer is likely to forward this information to the statistical reviewer with a request for a statistical reanalysis of the data. Likewise, the pharmacology reviewer may work closely with the statistical reviewer in evaluating the statistical significance of potential cancer-causing effects of the drug in long-term animal studies.

When the technical reviews are completed, each reviewer develops a written evaluation of the NDA that presents their conclusions and their recommendations on the application. The division director or office director then evaluates the reviews and recommendations and decides the action that the division will take on the application. The result is an action letter that provides an approval, approvable or non-approvable decision and a justification for that recommendation.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.


Back to The New Drug Development Process

 
Email thie page to a friend. Email This Page
to a Friend
Print this page. Print This
Page
© 1997 - 2023 Info.Resource, Inc. All rights reserved.
Privacy Policy . Cookie Policy . Terms of Use . About . Advertising

UtahLifeScience.com is owned and published by Info.Resource, Inc.