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CDRH director Jeffrey Shuren says FDA and other international regulatory agencies are considering how to develop a harmonized prem...[ Price : $8.95]
CDRH approves an updated postmarket study plan submitted by Bayer to assess safety and efficacy issues involving its controversial...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion cautions Celator that a convention panel misbrands its investigation cancer drug CPX-3...[ Price : $8.95]
FDA grants Sage Therapeutics a breakthrough therapy designation for SAGE-547 for treating postpartum depression.[ Price : $8.95]
FDA warns Indias Pan Drugs about CGMP and data integrity violations in its manufacturing of finished pharmaceuticals.[ Price : $8.95]
BD submits a PMA application to FDA for its Onclarity HPV (human papilloma virus test.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Central Admixture Pharmacy Services, Healing Noni Co., Healing-Scents, Jack P. H...[ Price : $8.95]
FDA grants Catalyst Pharmaceuticals an orphan drug designation for Firdapse (amifampridine phosphate) for treating myasthenia grav...