A Look At The Center for Drug Evaluation and Research Novel Drug Approvals for 2016 & Why The Dr
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers medicines and other drugs, including fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens. According to the U.S. Food & Drug Administration in a report titled "A Review of CDER's Novel Drug Approvals for 2016" -- the report states that the CDER reviewed and approved 22 novel drugs, most of which have the potential to add significant clinical value to the care of thousands of patients with serious and life-threatening diseases. Nearly three out of four of these novel products - 73 percent - benefitted from at least one of FDA's programs to expedite drug development and review (i.e., Fast Tract designation, Breakthrough Therapy designation, priority review designation, accelerated approval). According to Regulatory Affairs Professional Society -- John Jenkins, Director of FDA's Office of New Drugs wrote
"For example, CDER approved five novel drugs in 2015 that had PDUFA goal dates in 2016. These early approvals benefited patients by making the drugs available sooner, but also decreased the total of novel drugs approved in 2016. Another factor was the number of Complete Responses (CR), which describe deficiencies in the application, precluding approval, with advice on what the sponsor needs to do for FDA to support resubmission of the application. CDER issued 14 CR letters for novel drugs in 2016, higher than in recent years." To get more in depth information on the CDER's approvals for 2016 click on the pictures below to read the articles.