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 submits these written comments in response to FDA’s notice in the Federal Register concerning “Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements.”
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.
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.
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.
CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”
Letter regarding FDA draft guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug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 These comments are focused on issues related to dietary supplements as referenced in the draft guidance.
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.
