CHPA recognizes the need for modernization of USP monographs. CHPA member companies are dedicated to fulfilling their commitment outlined in the letter to this Planning Committee on February 2, 2011.
CHPA strongly supports the unanimous votes by the advisory committees to add weight-based dosing directions to the existing age-based labeled dosing directions for children.
The aim of this paper is to estimate savings that could be achieved by reducing unnecessary visits to primary care physicians for patients who can address symptoms with appropriate use of OTC medicines.
Letter regarding FDA draft guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application.” These comments are focused on issues related to dietary supplements as referenced in the draft guidance.
