Federal Register Notice: FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will meet 7/22-23/08, from 8:30 a.m. to 5 p.m. at FDA, CDER Conference Room 1066, 5630 Fishers Lane, Rockville, MD. On 7/22, the committee will: (1) Receive presentations from the Office of Pharmaceutical Science (OPS) and discuss current thinking on the use of nanotechnology in drug manufacturing, drug delivery, or drug products, and (2) receive an update from OPS, discuss, and make comments on current strategies and directions for the testing of lead in pharmaceutical products.
On 7/22, the committee will: (1) Receive and discuss presentations from the Office of Generic Drugs (OGD) on the bioequivalence methods for locally acting drugs that treat gastrointestinal conditions, (2) receive and discuss presentations from OGD on the use of inhaled corticosteroid dose-response as a means to establish bioequivalence of inhalation drug products, and (3) receive and discuss presentations from OPS on the drug classification of orally disintegrating tablets as a separate dosage form, and the need for subsequent guidance on expectations and recommendations that would be required for applications proposing the dosage form. Contact Diem-Kieu Ngo, (301) 827-7001. To view this notice, click here.