Briefing Summary: US FDA Asks Advisory Committees If Additional Restrictions on Pediatric Use of Codeine Are Warranted – DEC 10, 2015 (PADAC-DSRM)

The US FDA has posted details, including FDA Briefing Materials, for the Thursday, December 10, 2015 joint meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee (DSRM). The Committees will discuss the safety of codeine in children 18 years of age and younger and vote on whether to recommend new restrictions on its use.

See the SAC Tracker report