FDA Guidance on Antibiotics, Abuse-Deterrent Formulations Forthcoming, CDER Official Says

April 25, 2012
CDER this year plans to release draft guidance on abuse-deterrent formulations and nine guidances — both drafts and updates — clarifying the FDA’s views on antibiotic development, a CDER official says. “Watching how things have evolved over the last several years, we recognize we need to revisit some of those guidances to make sure we’re talking about how best to do antibiotic trials, in addition to what the best science tells you to do,” CDER Deputy Director Douglas Throckmorton said.
Drug Industry Daily