CHPA welcomes the underlying rationale for the proposed rule, including the move by the FDA towards global harmonization of safety reporting requirements in alignment with the EU and Japan.
This Citizen Petition requests the Commissioner of Food and Drugs to take the following action with respect to the Final Monograph for OTC Sunscreen Drug Products.
Comments regarding "Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph".
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.
Letter to Daniel E. Troy, Esq. regarding whether there should be different trade-name evaluation procedures for different classes of drugs (Rx versus OTC).
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.
We understand that FDA is considering a switch of a second generation antihistamine, from prescription to OTC status, over the objections of the company. CHPA opposes a policy to force switch over the objections of the drug sponsor.
