The Center for Drug Evaluation and Research (CDER) approved 22 novel drugs in 2016 1. Although 73% of these novel drugs benefitted from at least one of FDA’s programs to expedite drug development and review 1, a recent Pharmacy Times report indicates that the 22 drugs represent the lowest number of drug approvals in any year since 2010 2. Several factors contributed to the decline in drug approvals seen in 2016. One of these factors was the number of Complete Responses (CR). These describe deficiencies in the application, with advice on the actions that the drug sponsor need to make for the FDA to support resubmission of the application1. There were 14 CR letters issued by the CDER for novel drugs in 2016, and the principal deficiency for several of the applications was failure to comply with FDA’s current Good Manufacturing Practice (cGMPs) regulations1. For more information, see here.

 

References

  1. Jenkins, J. (2017, January 04). FDA Voice. Retrieved January 08, 2017, from A Review of CDER’s Novel Drug Approvals for 2016: http://blogs.fda.gov/fdavoice/index.php/author/mcooper/
  2. Toich, L. (2017, January 06). Pharmacy Times. Retrieved January 08, 2017, from FDA Drug Approvals Drop in 2016: http://www.pharmacytimes.com/news/fda-drug-approvals-drop-in-2016