CHPA is pleased to provide comments on behalf of our members in response to the notice regarding the “acts, policies, and practices of China determined to be unreasonable or discriminatory and to burden or restrict U.S. commerce.”
CHPA welcomes the opportunity to comment on Nicotine Replacement Therapies (NRT). A number of our member companies hold new drug applications or abbreviated new drug applications for NRT. As such, we have an interest in the subject matter of FDA’s notice.
CHPA appreciates that FDA has taken the time to review the data associated with certain isolated or synthetic carbohydrates not listed as a dietary fiber and looks forward to engaging with FDA in efforts to clarify and improve the regulation of all dietary supplements.
Here CHPA provides feedback on FDA's proposed development of an authorized list of pre-Dietary Supplement Health and Education Act (DSHEA) dietary ingredients.
CHPA respectfully submits comments to the Commission notice regarding public interest issues raised by Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Ltd. (“Amarin”) in its Complaint concerning Omega-3 (ω-3) products.
Herein CHPA provides comments on Citizen Petition #FDA-2016-P-43881, which requests an amendment of the marketing status for loperamide (Imodium) from nonprescription to prescription.
On behalf of the CHPA Dietary Supplements Committee, we are writing to express our concern with the recent decision by the Joint Committee to include certain elements of 21 CFR 117 within the consensus-based standard for dietary supplements.
We are supportive of the International Pharmaceutical Excipient Council of The Americas' recommendations detailed in their correspondence that USP remove references to dietary supplements and their ingredients.
Letter regarding modernization of the USP compendia for OTC medicines. CHPA supports improving the compendial test methods and establishing product standards for safety.
