Rx-to-OTC Switch

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Enclosed herein are comments on "Guidance for Industry: Self-Selection Studies for Nonprescription Drug Products."

Nov 15, 2011

CHPA comments on proposed recommendations for the reauthorization of the Prescription Drug User Fee Act.

Oct 31, 2011

CHPA and its member companies have an interest and expertise in label comprehension studies and support FDA's efforts to develop guidance for industry on this important topic.

Jul 30, 2009

CHPA comments on issues associated with the public health benefit of certain drugs being available without a prescription, but only after intervention by a pharmacist.

Dec 17, 2007

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

Sep 11, 2006

We understand that FDA is considering a switch of a second generation antihistamine, from prescription to OTC status, over the objections of the company. CHPA opposes a policy to force switch over the objections of the drug sponsor.

Mar 26, 2003

This submission represents CHPA's detailed written comments as follow-up to the June meeting and is intended to complement the Association's oral presentation.

Aug 25, 2000

CHPA presentations at Food and Drug Administration OTC Part 15 hearing - Over-the-Counter Medications: A Success Story.

Jun 28, 2000

Explore consultants who can assist with communications, regulatory policy, strategy, operations, compliance, product development, and more.

Learn about the process of transferring FDA-approved prescription medications to nonprescription, over-the-counter status.

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