Submissions

CHPA applauds and is strongly supportive of FDA's re-examination of the monograph system in an effort to complete the OTC Drug Review.

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.

There are several scientific and technical issues the agency should consider prior to issuing a final determination regarding partially hydrogenated oils (PHOs).

CRN and CHPA take this opportunity to share our views on the Food and Drug Administration’s Federal Register notice entitled, “Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information.”

CHPA strongly believes that companies should continue to utilize a set of robust metrics to drive internal continuous improvement activities to enhance product quality and ensure consumer safety.

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.

Echoing earlier comments submitted to the agency, CHPA and its member companies marketing dietary supplement products support the presumption of safety for dietary ingredients outlined in the 1994 passage of DSHEA.

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.