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Shire says it plans to resubmit during the first quarter of 2016 its NDA for lifitegrast for treating signs and symptoms of dry ey...[ Price : $8.95]
FDA releases FDA-483s from inspections at two Theranos manufacturing facilities.[ Price : $8.95]
FDA posts a guidance on Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an...[ Price : $8.95]
FDA clears a Masimo 510(k) for MightySat Rx, a fingertip pulse oximeter that uses the companys SET Measure-through Motion and Low ...[ Price : $8.95]
Federal Register Notice: FDA develops a list of bulk drug substances that can be used to compound drugs in accordance with the 503...[ Price : $8.95]
Federal Register Notice: FDA develops a list of bulk drug substances that can be used to compound drug products in accordance with...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on information collection associated with electronic device registration and listing.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503...