CDER Report on Novel Approvals Highlights Firsts in 2017
By Zachary Brennan -
Published 10 January 2018
2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy
Tags: 2017 novel drug approvals, CDER report, Woodcock, Gottlieb