OTC Medicines

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Request for extension of comment period regarding Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs.

Oct 12, 2006

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

Sep 11, 2006

While DXM is used safely by millions of Americans, some teenagers and young adults are intentionally abusing large quantities of medicines containing DXM in an effort to get high.

Jul 26, 2006

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.

Jun 5, 2006

The objectives of this study are: To evaluate the efficacy and safety of 10% and 20% benzocaine gel for the relief of toothache, compared to placebo and to each other; and to assess the subject’s compliance with the dosing directions on the proposed label.

Jun 1, 2006

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.

Jan 17, 2006

The purpose of the study was to compare the costs of upper respiratory infection (URI) treatment with over-the-counter (OTC) medications versus non-treatment.

Jan 11, 2006

With this letter, the Consumer Healthcare Products Association expresses its great interest in the selection of the industry representative to serve on the Nonprescription Drugs Advisory Committee.

Nov 28, 2005

CHPA sees no need for the agency to initiate a rulemaking on this matter. Sufficient precedent already exists for an active drug ingredient to be simultaneously marketed in both prescription and OTC drug products based on narrow distinctions.

Oct 31, 2005

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