The CHPA External Analgesics Task Group submits these comments in response to FDA's reopening of the administrative record for the OTC external analgesics rulemaking and the agency's proposal to amend the tentative final monograph for external analgesics.
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.
Comments on the U.S. government’s position concerning draft vitamin and mineral supplement guidelines before the Codex Committee on Nutrition and Foods for Special Dietary Uses.
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.
CHPA supports rules governing the regulation of dietary supplements as a special type of food. The association has long advocated Good Manufacturing Practices for dietary supplements.
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).
