Comments regarding a citizen petition requesting that the Commissioner of Food and Drugs add a warning to the labeling of all nonprescription drug products containing ingredients with anticholinergic or histamine inverse agonist effects to indicate that products with these ingredients can cause a confusional state.
The Petitioners request that the Commissioner of Food and Drugs add a warning to the labeling of all nonprescription drug products containing an ingredient with “anticholinergic or histamine H1 inverse agonist effects” noting that the product can cause a confusional state.
Comments regarding guidance for clinical investigators, sponsors, and institutional review boards on investigational new drug applications - Determining whether human research studies can be conducted without an investigational new drug application.
So far, 31 states have adopted real-time, stop-sale technology. The blocking technology monitors all nonprescription PSE purchases in real-time to prevent meth criminals from exceeding legal limits.
CHPA and its member companies strongly support the OTC Monograph System, which effectively and efficiently regulates the majority of OTC medicines on the U.S. market.
The members of the stakeholder selection committee respectfully submit these candidates to serve as the non-voting industry representative and alternate (as needed) for the FDA Pediatric Advisory Committee.
Summary and recommendations from The Gerontological Society of America and Consumer Healthcare Products Association National Summit on Over-the-Counter Medication Behaviors of Older Adults.
