OTC Medicines

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.

Today, the manufacturers of OTC medicines containing pseudoephedrine call on Congress to improve the Combat Methamphetamine Epidemic Act by requiring a unified, national electronic tracking system to block illegal sales of PSE‐containing 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.