Because of FDA's safety concerns regarding the control and monitoring of levomethorphan, CHPA supports the control of levomethorphan as an impurity and respectfully submits the following comments regarding the proposed updates to the DXM monograph as proposed in the IRA published in PF 40(3).
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.
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.
There are several scientific and technical issues the agency should consider prior to issuing a final determination regarding partially hydrogenated oils (PHOs).
CRN and CHPA take this opportunity to share our views on the Food and Drug Administration’s Federal Register notice entitled, “Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information.”
