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.
Briefing book for the Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee, June 29-30, 2009.
CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”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.
The Structured Product Labeling OTC sub-team appreciates the opportunity to comment on the collection of information pertaining to the July 2008 Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing.
The undersigned trade associations are writing to request that the Commission exercise enforcement discretion with respect to the new general conformity certification requirement imposed by the Consumer Product Safety Improvement Act of 2008 (CSPIA).
