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Comments regarding guidance for clinical investigators, sponsors, and institutional review boards on investigational new drug applications - Determining whether human research studies can be conducted without an investigational new drug application.

Apr 7, 2014

This report builds upon current insights with findings from a new survey which examines two important stakeholder groups and analyzes what drives these groups’ use and trust in OTC medicines.

Mar 6, 2013

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

Nov 15, 2011

Letter regarding FDA draft guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application.” These comments are focused on issues related to dietary supplements as referenced in the draft guidance.

Jan 11, 2011

CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”

Mar 24, 2009

The objective of this study is to outline and quantify the benefits of OTC heartburn therapy for consumers and the healthcare system in the context of treatment satisfaction and cost savings.

Dec 7, 2008

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

Sep 11, 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

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.

Aug 9, 2004

Enclosed for FDA review are final reports on 2-year carcinogenicity studies with topically applied benzoyl peroxide gels in F344 rats and B6C3F1 mice submitted by the Benzoyl Peroxide Study Group of CHPA.

Dec 27, 2001

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