APS E-News | Advocacy Update Report | September 2018
FDA to Withdraw 2014 Analgesic Guidance Document
The FDA recently announced it plans to withdraw a 2014 guidance document for developing pain medicines in favor of a more focused approach to promote nonopioid drugs.
The agency plans to withdraw its 2014 analgesic guidance document, which called for drug manufacturers to undertake broad studies of treatments for chronic pain. At least four new guidance documents over the next 6 to 12 months will instead promote a more focused and efficient approach that allows the companies to focus on specific kinds of pain, FDA Commissioner Scott Gottlieb said.