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The CDER Office of Generic Drugs issues a MAPP with the process for reviewing and approving or denying requests for consolidation ...[ Price : $8.95]
Cubist asks FDA to impose specific bioequivalence requirements on ANDA and 505(b)(2) NDA applicants citing Dificid as the referenc...[ Price : $8.95]
CDER says that a main fundamental goal for negotiating the Generic Drug User Fee Act reauthorization will be to align with Industr...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Aros Surgical Instruments and SSM Health Care dba SSM St. Clare Health Center.[ 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 ...