Other Issues

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).

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 strongly believes that companies should continue to utilize a set of robust metrics to drive internal continuous improvement activities to enhance product quality and ensure consumer safety.

CHPA requests that FDA publish a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen OTC drugs subject to the ongoing internal analgesic, antipyretic, and antirheumatic monograph proceedings to including labeling on products that provide instructions for use in children aged six months to two years.

CHPA's comments on this Draft Guidance are organized into three General Comments and Detailed Comments by Section.