CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Best Practices in Developing Proprietary Names for Drugs”. CHPA members hope the Agency will find the suggested revisions in these comments informative as the final version of the guidance is developed.
CHPA applauds FDA's efforts to amend labeling regulations for conventional foods and dietary supplements in order to provide updated nutrition information to consumers.
CHPA strongly supports USP's efforts to address impurity control in drug substances and products. Overall the newly revised chapters provide reasonable guidance and direction for controlling organic impurities.
These comments are primarily focused on the use of Ultra-High Performance Liquid Chromatography as the method of choice for assay and organic impurities.
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.
