Blog Category: Drugs

Development and Regulation of Abuse-Deterrent Opioid Medications – FDA Public Meeting

The FDA is hosting a public meeting on October 30 and 31, 2014 to discuss the development, assessment, and regulation of abuse-deterrent formulations of opioid medications. The meeting will focus on scientific and technical issues related to the development and …

FDA Modifies Label for ER/LA Opioids

The Food and Drug Administration yesterday announced changes to the labeling requirements for long-acting pain medication. In addition, FDA has ordered new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.

The modified indication, …

FDA Offers Draft Guidance on Abuse-deterrent Opioids

The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties. It describes the FDA’s current thinking about the studies that should be conducted to demonstrate …