Submissions

CHPA's comments on this Draft Guidance are organized into three General Comments and Detailed Comments by Section.

CHPA supports advancing modernization of USP's quality monographs, updating and improving the compendial test methods and establishing product standards which can provide an additional measure of safety for OTC products.

Enclosed herein are comments on "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device: Public Meeting: Request for Comments".

We take this opportunity to voice our support of comments submitted by the Council for Responsible Nutrition (CRN) regarding the appropriate interpretation of the term “chemically altered” under Section 413(a)(1) of the Federal Food, Drug, and Cosmetic Act.

We take this opportunity to voice our support of comments submitted by the American Herbal Products Association regarding proposed revisions to the agency's Draft Guidance on New Dietary Ingredient Notification.

CHPA supports improving the compendial test methods and establishing product standards for levels of elemental impurities which can provide an additional measure of safety for OTC products.

Letter to Dr. Shawn Dressman regarding U.S. Pharmacopeia's Stimuli article: USP's Monographs in Support of FDA's OTC Monograph System: Modernization Opportunities.

CHPA welcomes the opportunity to comment on the above captioned request published in the January 18, 2013 Federal Register.