[ Price : $8.95]
AstraZeneca petitions FDA to require Seroquel XR ANDA applicants to include labeling covering the risk of hyperglycemia, diabetes,...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on reprocessed single-use device labeling.[ Price : $8.95]
PhRMA cautions FDA that a new guidance on clinical investigator financial disclosure should not hamper drug research.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Bionet Co, Dr. Fosters Essentials, Sichuan Pharmaceutical, and Uriel Pharmacy.[ Price : $8.95]
Washington Legal Foundation says that FDA should withdraw its draft guidance on product classification or submit it for notice and...[ Price : $8.95]
FDA Webview editor Jim Dickinson comments on new HHS-wide restrictions on communications between the departments employees and mem...[ Price : $8.95]
FDA says it has not yet reached a conclusion about the potential increase blood clot risk associated with the use of drospirenone-...[ Price : $8.95]
CDER director Janet Woodcock says the agency is considering options to ease the development path for antibiotics.