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
 
Facilities
 

EquipNet Auction: Looking to sell your pre-owned equipment? Sell it Now! Don't Wait!

Our Newest Cartoon Illustrates: "Women's History Month"


Sponsor/FDA Meetings (End of Phase 2)

The New Drug Development Process.

The primary focus of "end of Phase 2" meetings is to determine whether it is safe to begin Phase 3 testing. This is also the time to plan protocols for Phase 3 human studies and to discuss and identify any additional information that may be required to support the submission of a new drug application. It is also intended to establish an agreement between the Agency and the sponsor of the overall plan for Phase 3 and the objectives and design of particular studies. These meetings avoid unnecessary expenditures of time and money because data requirements have been clarified.

One month prior to the "end of the Phase 2" meeting, the sponsor should submit the background information and protocols for Phase 3 studies. This information should include data supporting the claim of the new drug product, chemistry data, animal data and proposed additional animal data, results of Phase 1 and 2 studies, statistical methods being used, specific protocols for Phase 3 studies, as well as a copy of the proposed labeling for a drug, if available. This summary provides the review team with information needed to prepare for a productive meeting.

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

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