feb 4, 2016 - FDA leaders, in response to the opioid abuse
epidemic, called for a far-reaching action plan to
reassess the agency’s approach to opioid
medications. The plan will focus on policies aimed
at reversing the epidemic, while still providing
patients in pain access to effective relief.
FDA released five postmarketing (PMR)
requirements announced on September 13, 2013,
and replaced them with 11 PMRs (10
postmarketing studies and one clinical trial)
because the 10 postmarketing observational
studies and one