BioCentury
ARTICLE | Politics & Policy

FDA to hold meeting on opioid postmarketing requirements

April 23, 2014 12:03 AM UTC

FDA is holding a public meeting on May 19-20 to obtain stakeholder input on the design and conduct of postmarketing requirements for extended-release and long-acting opioids. In September, FDA announced classwide labeling changes and new postmarketing study requirements to assess abuse and other risks. The agency is holding the meeting to obtain input on the studies for manufacturers of extended-release and long-acting opioids, who are required to submit final protocols for the new postmarketing requirements by August. The new postmarketing requirements include at least one study to quantitatively estimate the risks of misuse, abuse, addiction, overdose and death, as well as a trial to evaluate the risk of developing hyperalgesia, or increased sensitivity to pain (see BioCentury Extra, Sept. 10, 2013). ...