Submissions

CHPA supports FDA's proposal to discontinue the use of approvable letters and not approvable letters when taking action on NDAs.

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.

CHPA and its members share DEA's concerns regarding the diversion of pseudoephedrine, ephedrine, and phenylpropanolamine products. However, CHPA does not believe that the notice of proposed rulemaking provides interested parties an adequate record to evaluate and comment upon the security measures DEA now proposes.

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.

CHPA requests CFSAN to commit to the finalization of Good Manufacturing Practices for dietary supplements as one of its highest priorities for FY 2005.

CHPA comments on the proposed rule, which is intended to bring FDA regulations into compliance with section 17 of the Best Pharmaceuticals for Children Act.

CHPA welcomes the opportunity to provide comments to this proposed rule on nutrient content and health claims and supports the Agency’s efforts to facilitate the communication of truthful and non-misleading information to consumers.

CHPA submits these comments on behalf of member companies who market OTC drugs for urinary pain relief. Our comments are in response to FDA’s notice requesting information about marketed urinary analgesic/antiseptic drug products that have not yet undergone FDA evaluation.

The Consumer Healthcare Products Association supports the Federal Highway Administration's interim final rule allowing pharmacy signs on federal-aid highways.