Submissions

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 However, should FDA decide to implement a program, we expect that FDA would publish a draft Guidance for Industry and we would provide further comment based on the criteria.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.

CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Best Practices in Developing Proprietary Names for Drugs”. CHPA members hope the Agency will find the suggested revisions in these comments informative as the final version of the guidance is developed.

CHPA applauds FDA's efforts to amend labeling regulations for conventional foods and dietary supplements in order to provide updated nutrition information to consumers.

CHPA strongly supports USP's efforts to address impurity control in drug substances and products. Overall the newly revised chapters provide reasonable guidance and direction for controlling organic impurities.

These comments are primarily focused on the use of Ultra-High Performance Liquid Chromatography as the method of choice for assay and organic impurities.