Health Law Advisor

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.

The federal government entered into a partial shutdown at midnight on Saturday, December 22, 2018. The implications of the ongoing shutdown are far-reaching, but its impact on the Food and Drug Administration (“FDA”) is of particular concern to members of FDA-regulated industries and those with a role in ensuring the public health. Thousands of FDA employees considered non-essential were furloughed and, consequently, routine regulatory and compliance activities at FDA were put on hold. On his Twitter account (@SGottliebFDA), Scott Gottlieb, M.D., Commissioner of the FDA ...

Last week both CDER and CDRH released a list of guidance documents they intend to develop or finalize over the next year.  However, it is interesting to note that the approach and information provided by each FDA center diverged significantly.  CDRH provided details as to the priority of guidances they plan on developing, offered specific metrics they will use to measure success, and opened up a docket to receive stakeholder comments.  CDER also provided a list of guidances; however the process to administer comments and specificity on what guidance documents would be prioritized was ...