In order to ensure the continued safe reporting of adverse events associated with our member's products and prevent consumer confusion, we strongly believe OTC and dietary supplement product incident reports should not be included in the CPSC safety incident database.
CHPA and its member companies have an interest and expertise in dosage delivery devices and support FDA's efforts to develop guidance for industry on this important topic.
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.
CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”
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.
These comments are submitted on behalf of CRN and CHPA in response to the FDA Notice and Request for Comments on the implementation of section 301(ll) of the Federal Food, Drug, and Cosmetic Act.