FDA Announces New Labeling and Postmarket Studies Requirements for Painkillers
On September 10, 2013, the FDA announced its plan to issue new regulations for labeling extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain. According to the FDA, the labeling changes “will include important new language to help health care professionals tailor their prescribing
The tragedy and pervasiveness of prescription drug abuse is well-documented. According to the latest National Survey on Drug Use and Health released last week, 1.9 million Americans used prescription painkillers for a nonmedical purpose for the first time in 2012. The tireless efforts of DEA and other law enforcement agencies to address this issue are
The DEA has announced an upcoming Manufacturer/Importer/Exporter Conference to be held in June 2013 at the National Harbor, Gaylord National Resort & Convention Center. “The purpose of this conference is to provide a forum to present federal laws and regulations that affect the pharmaceutical and chemical manufacturing, importing, and exporting industry and to discuss practices
DEA’s position on oxycodone is clear — more or less. In DEA’s letter to FDA supporting a petition to restrict the approved labeled use of oxycodone to “severe pain,” DEA said that “abuse of prescription opioids have increased markedly over the past decade.” In the letter DEA also expressed support for the legitimate and beneficial