U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Prescription Drug User Fee Amendments
  5. Exhibit 5-3 long description
  1. Prescription Drug User Fee Amendments

Exhibit 5-3 long description

a. Sponsor Motivation for Pilot 2 Participation Five out of seven companies interviewed said they participated because they wanted increased communication. Two companies cited a press release, cited accelerated development and five companies said they wanted guaranteed feedback. 

b. Potential Impact of Timely FDA Guidance During Drug development Examples of sponsor decision points that may have been influenced by timely FDA feedback would be 1) whether to conduct additional carcinogenicity studies, 2) whether to expand the patient population size or 3) whether they had the appropriate pivotal trial endpoints or if they should test an array of endpoints.

Back to Top