CHPA and its member companies who make oral pediatric cough and cold medicines strongly believe that the current data support the safety and efficacy of these medicines when used as directed; however, we are committed to working with FDA to better enhance consumer use of these products.
CHPA subcommittee hearing statement in support of federal legislation ensuring that raw, unfinished dextromethorphan does not fall into the wrong hands, and that minors under 18 are not allowed to purchase cough medicine.
CHPA comments on issues associated with the public health benefit of certain drugs being available without a prescription, but only after intervention by a pharmacist.
CHPA appreciates the opportunity to provide comments on FDA’s draft guidance for industry on adverse event reporting for dietary supplements and nonprescription human drug products marketed without an approved application.
CHPA's voluntary plan to address concerns surrounding the safety and efficacy of OTC oral pediatric cough and cold medicines. CHPA, on behalf of its member companies, commits to the following initiatives.
CHPA comments on the proposed rule, which proposes new warning and other labeling requirements for internal analgesic, antipyretic, and antirheumatic OTC drug products.
FDA issued a proposed rule on labeling requirements for OTC human drugs. The announcement proposed a definition for “convenience-size” OTC drug packages as well as the option of alternative labeling requirements for these products. CHPA welcomes the opportunity to comment on the proposed rule changes.