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Articles: Regulatory Issues |
Watson Confirms Filing of Abbreviated New Drug Application for Generic Sanctura XR(R)
Watson Pharmaceuticals, 07/16/09
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Servier Singled Out for New EU Antitrust Investigation
PharmExec, 07/16/09 Watson Pharmaceuticals Receives a Complete Response Letter for Its 24-Week Formulation of TRELSTAR (triptorelin pamoate) NDA from US FDA
Watson Pharmaceuticals, 07/15/09
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Update on Status of Rivaroxaban Complete Response Letter From U.S. FDA
BayNews International, 07/15/09
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Covidien Initiates Nationwide Voluntary Recall of Sodium Chromate Cr-51 Injection, Lot #370-9004
Covidien, 07/15/09 The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US
BioPharm, 07/13/09
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Medtronic Voluntarily Recalls Specific Lots of Paradigm Quick-Set Infusion Sets in the United States
Medtronic, 07/13/09
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FDA Boosts Warnings on Propoxyphene Pain Meds
PharmExec, 07/09/09 New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
Amylin Pharmaceuticals, 07/08/09
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Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Cell Therapeutics, 07/08/09
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King Provides Additional Information on the REMOXY NDA Resubmission Plan
King Pharmaceuticals, 07/08/09
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CareFusion files amended Form 10 Registration Statement with SEC
Cardinal Health, 07/08/09
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Acetaminophen must be made safer, FDA panelists agree
American Pharmacists Association, 07/06/09
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Acura and King Receive FDA Complete Response Letter Regarding Acurox
King Pharmaceuticals, 07/06/09
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Takeda Receives FDA Complete Response Letter for Alogliptin, An Investigational Treatment for Type 2 Diabetes
Takeda Pharmaceuticals North America, 07/02/09 Examination of the Relationship Between Oncology Drug Labeling Revision Frequency and FDA Product Categorization
American Journal of Public Health, 07/01/09 Roche Discontinues and Plans to Delist Accutane in the U.S.
Roche, 07/01/09
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New EU Committee Leaves Member States Out In The Cold
PharmExec, 07/01/09 Biopure Receives Notice of Nasdaq Delisting
BioPure, 07/01/09
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Novartis receives Complete Response letter from the US Food and Drug Administration for its investigational vaccine Menveo
Novartis, 07/01/09
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