Codeine Concerns Cough Up FDA's OTC Monograph Problems
Executive Summary
Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative process and to authorize a monograph user fee program.
You may also be interested in...
Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote
An updated draft includes a provision requiring FDA to report annually to the Energy and Commerce Committee and to the Senate HELP Committee on the agency's evaluation of the cough and cold monograph to determine whether to impose more stringent limits on formulations allowed for use by children under age 6.
Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote
An updated draft includes a provision requiring FDA to report annually to the Energy and Commerce Committee and to the Senate HELP Committee on the agency's evaluation of the cough and cold monograph to determine whether to impose more stringent limits on formulations allowed for use by children under age 6.
Opioids: FDA Eyes Better Prescriber Education, But Academics Urge Promotion Crackdown
US agency is convening two-day workshop on federal efforts to support healthcare provider education about pain management and safe use of the drugs; two University of Washington researchers say agency needs to exercise stricter oversight of opioid marketing and promotion.