CHPA understands the proposed framework in the notice is limited to prescription drugs. We have an interest in this subject, however, since we could foresee the policies described have utility for nonprescription drugs under new drug applications.
The 2018 results from the National Institute on Drug Abuse and University of Michigan's annual drug abuse survey, Monitoring the Future, show that the percentage of teens using OTC cough medicine containing dextromethorphan to get high remains at three percent.
Herein, CHPA provides feedback on the Office of Environmental Health Hazard Assessment (OEHHA) proposal to modify Section 25821, subsections (a) and (c)(2), Level of Exposure to Chemicals Causing Reproductive Toxicity.
CHP Canada and CHPA respectfully submit this brief to the Office of Information and Regulatory Affairs within the Office of Management and Budget in response to the US-Canada Regulatory Cooperation Council Request for Information (83 FR 50689).
Yesterday, Pennsylvania Governor Tom Wolf signed into law HB 1951, legislation prohibiting the sale of over-the-counter (OTC) medicines containing the cough suppressant dextromethorphan (DXM) to minors.
In a study newly published in the medical journal Clinical Toxicology, “therapeutic misuse” of OTC combination products containing acetaminophen was infrequent and declined over a 10-year period.
Herein, CHPA provides feedback on the Food and Drug Administration’s Nutrition Innovation Strategy, particularly as it relates to the agency’s development and implementation of a consumer education campaign.
Today, the Consumer Healthcare Products Association (CHPA) issued the following statement upon submitting comments to the Food and Drug Administration (FDA) regarding its draft guidance titled, “Innovative Approaches for Nonprescription Drug Products.”
CHPA members look forward to publication of the final guidance and the companion proposed rule. Together these regulatory documents will provide insights that sponsors can consider when designing research and development proposals for Rx to OTC switch programs.
