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Comments regarding a proposed rule on electronic submission requirements for postmarketing safety reports for human drug and biological products.

Comments regarding a citizen petition requesting that the Commissioner of Food and Drugs add a warning to the labeling of all nonprescription drug products containing ingredients with anticholinergic or histamine inverse agonist effects to indicate that products with these ingredients can cause a confusional state.

Letter from the Consumer Healthcare Products Association, the Food Marketing Institute, the Healthcare Distribution Management Association, and the National Association of Chain Drugstores regarding controlled substances and Lis I chemical registration application fees.

CHP Canada and CHPA respectfully submit this brief to the Office of Information and Regulatory Affairs within the Office of Management and Budget in response to the US-Canada Regulatory Cooperation Council Request for Information (83 FR 50689).

The following comments are submitted by the Joint Oral Care Task Group CHPA and the Cosmetic, Toiletry, and Fragrance Association with respect to the Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention.

CHPA appreciates this opportunity to provide comments on FDA Guidance detailing the agency’s process for evaluating data on the beneficial physiological effects of isolated or synthetic non-digestible carbohydrates.

CHPA appreciates the opportunity to provide comments on FDA’s draft guidance for industry on adverse event reporting for dietary supplements and nonprescription human drug products marketed without an approved application.