Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 6/15-16, from 8 a.m. to 5 p.m. at the Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD. On 6/15 the committee will discuss class labeling of antihypertensive drugs based on the proximity of their data to outcome trials. On 6/16, the committee will discuss a Nitromed, Inc. NDA with a proposed trade name of Bidil (hydralazine HCl/isosorbide dinitrate) for heart failure, based on the results from the African American Heart Failure Trial. Contact Cathy Groupe, (301) 827-7001. To view this notice, click here.
