OTC Medicines

Comments regarding guidance for clinical investigators, sponsors, and institutional review boards on investigational new drug applications - Determining whether human research studies can be conducted without an investigational new drug application.

CHPA and its member companies strongly support the OTC Monograph System, which effectively and efficiently regulates the majority of OTC medicines on the U.S. market.

The members of the stakeholder selection committee respectfully submit these candidates to serve as the non-voting industry representative and alternate (as needed) for the FDA Pediatric Advisory Committee.

CHPA requests that FDA publish a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen OTC drugs subject to the ongoing internal analgesic, antipyretic, and antirheumatic monograph proceedings to including labeling on products that provide instructions for use in children aged six months to two years.

CHPA's comments on this Draft Guidance are organized into three General Comments and Detailed Comments by Section.