Letter to Daniel E. Troy, Esq. regarding whether there should be different trade-name evaluation procedures for different classes of drugs (Rx versus OTC).
These comments are submitted in response to the public meeting of June 26 on evaluating drug names for similarities, which was co-sponsored by the FDA, PhRMA, and the Institute for Safe Medication Practices.
CHPA supports the intent of the proposed rule to add a bar code to many medications intended to be dispensed in hospitals. We support the view that this rule will help arm busy healthcare professionals with technology to help avoid medication mistakes.
The Coalition is pleased that FDA has issued guidance that takes a risk-based approach to compliance. We strongly support this approach as a more realistic and effective way to protect public health.
CHPA supports efforts to reduce medication errors, including those that encompass errors in information acquisition by the consumer, who is the principal end user of self care products, and by health professionals as well.
Enclosed for FDA review are final reports on 2-year carcinogenicity studies with topically applied benzoyl peroxide gels in F344 rats and B6C3F1 mice submitted by the Benzoyl Peroxide Study Group of CHPA.
CHPA charged IOM to develop a proposed framework for categorizing and prioritizing DS ingredients based on safety issues, describe a process for developing a system of scientific reviews for evaluating the safety of DS ingredients, and develop at least six scientific reviews as prototypes for the system.
