OTC Medicines

In this submission the task group provides updated data on the safety of counterirritants administered via patched or other novel dosage forms.

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.

Comments regarding a proposed rule on electronic submission requirements for postmarketing safety reports for human drug and biological products.

CHPA's Internal Analgesics task group seeks the agency's clarification of three provisions of the final rule.

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CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”