Auxiliary Web Page for FDA Deadlines Study

Paper: D. Carpenter, E. J. Zucker, and J. Avorn. "Drug Review Deadlines and Safety Problems," New England Journal of Medicine 358 (13) (March 27, 2008) 28-35.

A paper that goes into the data in much greater detail is available here. Note that this paper is not yet published; corrections and comments are welcome.

A mathematical model predicting the relationships observed in the paper is available here. Note that this paper is incomplete and not yet published; corrections and comments are welcome.

A number of people have asked for examples of drugs that were approved in the two-month window before the deadlines and later experienced post-marketing regulatory events. A partial list is available here.

Response to Inquiry from the FDA: On March 25, 2008, at 3:34 PM, I received a message from Dr. Clark Nardulli of the FDA, stating that "We (the FDA) have been asked to comment on the article. We have been unable to replicate your results with our data and therefore have questions." My response to Mr. Nardulli, completed early this mornnig, is posted here.