I recommend against relying on any data I provide in today’s post.  I hope the data are at least somewhat accurate.  But they are not nearly as accurate as they should be, or as they could be, if FDA just released a key bit of information they have been promising to share for years.

One of the ways data scientists can provide insights is by grafting together data from different sources that paint a picture not seen elsewhere.  What I want to do is join the clinical trial data at www.clinicaltrials.gov with the data maintained by FDA of approved drugs, called drugs@FDA.  But I can’t, at least not with much accuracy.

Continue Reading Unpacking Averages: Connecting Published Clinical Trials with FDA Drug Approvals

On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions.  Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal

On May 9, 2017, Scott Gottlieb, M.D. was confirmed by the Senate as the new Commissioner of the Food and Drug Administration (“FDA”).  As Commissioner, he will be immediately responsible for shaping FDA policy on a number of current issues, including addressing and implementing several mandates stemming from the 21st Century Cures Act, (“Cures