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FDA finalizes a guidance on product development under the Animal Rule when human efficacy studies are not ethical or feasible.[ Price : $8.95]
FDAs Los Angeles District Office warns Aros Surgical Instruments about Quality System and other violations in its manufacturing of...[ Price : $8.95]
Federal Register Final order: FDA classifies an autosomal recessive carrier screening gene mutation detection system into Class 2.[ Price : $8.95]
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...