Other Issues

Letter to the FDA's LT Darrell Lyons requesting additional time to address the Nonprescription Drugs Advisory Committee.

CHPA appreciates the comments of FDA in the February 2006, feedback letter and understands that these comments are FDA’s best advice on designing a protocol to address the safety and efficacy of benzocaine. We have included a revised final protocol for your final review.

CHPA has supported and continues to support the timely provision of complete and accurate product information to healthcare professionals and patients in an easily accessible format, and commends the Agency for considering new approaches to disseminating emerging drug safety-related data.

CHPA appreciates the opportunity to provide comments concerning U.S. Government positions in preparation for the 33rd session of the Codex Committee on Food Labelling of the Codex Alimentarius Commission.

In considering the safety of NSAIDs, the use of OTC NSAIDs should be clearly distinguished from long-term prescription NSAID use. OTC medicines have a different overall benefit-to-risk equation and a wider margin of safety than prescription NSAIDs.

Letter to Dr. Williams regarding "Development of a New Official Compendium, Separate from USP-NF, for Articles Not Legally Marketed in the U.S."

Comments on proposed revisions to the Proposition 65 prioritization procedure submitted by the Consumer Healthcare Products Association, Grocery Manufacturers of America, and the National Food Processors Association.

The Industry Coalition on 21 CFR Part 11 is pleased to submit the attached Citizen Petition to FDA for consideration. The Coalition comprises 13 trade associations representing manufacturers of products including foods, drugs, cosmetics, veterinary drugs, and medical devices.

We would like to commend the U.S. Government position previously taken on the vitamin and mineral supplement draft guidelines, and encourage the U.S. Government to maintain a similar position.