CHPA released the following statement in support of today’s enactment of a Washington State law prohibiting the sale of OTC medicines containing the cough suppressant dextromethorphan (DXM) to minors.
CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”.
FDA intends to expand the scope of Redbook to include chemical safety assessments for all products over which FDA's Center for Food Safety and Applied Nutrition has statutory authority. We urge FDA to provide clear and specific guidance for applying these principles within each particular context.
Please accept this letter as an official request from the CHPA to participate in the selection process for nonvoting industry representatives for several public advisory committees for the Center for Drug Research & Evaluation.
CHPA appreciates the opportunity to provide comments to the FDA in response to “Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen”. CHPA and its member companies have an interest and expertise in acetaminophen-containing OTC products and support FDA’s efforts to improve the safe use of acetaminophen.
