Submissions

Please accept this letter as an official request from the CHPA to participate in the selection process for nonvoting industry representatives for several public advisory committees for the Center for Drug Research & Evaluation.

Letter to Principal Scientific Liaison, U.S. Pharmacopeia, regarding Proposals for Developing Compendial Quality Standards for OTC Drugs.

These comments touch on several of the goals identified by ODS in the Progress Report.

CHPA appreciates the opportunity to provide the Office of Dietary Supplements (ODS) with comments on their Strategic Plan 2010-2014 Progress Report.

We ask that in its review of the Proposed Orders, FDA take our framework into consideration when making its GRASE determinations.

CHPA appreciates the opportunity to provide comments to the FDA in response to “Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen”. CHPA and its member companies have an interest and expertise in acetaminophen-containing OTC products and support FDA’s efforts to improve the safe use of acetaminophen.

In principle, CHPA supports an early approval program for proposed proprietary drug names. However, should FDA decide to implement a program, we expect that FDA would publish a draft Guidance for Industry and we would provide further comment based on the criteria.

Letter to Mr. Brown regarding U.S. Pharmacopeia draft publication, "General Chapter <909> Uniformity of Dose from Oral Suspensions in Multi-Unit Containers."

CHPA is supportive of the proposal to rely on a general chapter structure and publishing quality standards for new compendial drug product monographs. We would however request the publication of Chapters <321> and <327> be delayed until a number of details can be addressed.