Exhibit 1181 ยท Journal article
Approval Times for New Drugs: Does the Source of Funding for FDA Staff Matter?
The amount of funding for FDA staff appears to be a much more important influence on NDA review time than the source of funding.
Assesses 843 new drug applications submitted 1977-2000 and finds that adding FDA staff shortens review time while the source of the money matters much less than the amount. The authors give this as evidence that PDUFA fee money mattered through staffing, not through industry influence. Abstract read (PubMed).
- Source
- Carpenter, Chernew, Smith and Fendrick, Health Affairs (web exclusive) 22(Suppl 1):W3-618-W3-624
- Date
- 2003
- Quoted from
- Abstract
- Grade
- Peer-reviewed
- Document
- https://doi.org/10.1377/hlthaff.w3.618
- Accessed
- 2026-11-10
- Cited by
- Findings citing this exhibit
- Note
- Standing note: before/after comparison of one agency; speed was the outcome, not safety or capture. Authored by the Carpenter who edited the capture volume, so the same scholar supplies the null on fees and the framework on degrees of capture.