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FDAs New England District Office warns Atrium Medical Corp. about Quality System violations in its manufacturing of several medica...[ Price : $8.95]
CDER Office of Medical Policy deputy director Rikin Mehta says FDA is moving forward with its exploration of whether some drugs co...[ Price : $8.95]
CDER plans to replace Medication Guides, patient-package inserts, and other consumer medication information handed out at pharmaci...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Atrium Medical, BioHealth Solutions, Steven W. Boyce, Global Source Management &...[ Price : $8.95]
CDRH posts a transcript of a workshop held 8/30 on Post Approval Studies: Design, Methodology, and Role in Evidence Appraisal Thro...[ Price : $8.95]
Titan Pharmaceuticals files a 505(b)(2) NDA for Probuphine (buprenorphine hydrochloride), indicated for treating opioid dependence...[ Price : $8.95]
Warner Chilcott petitions FDA asking it to tighten bioequivalence criteria for ANDA sponsors seeking approval for generic copies o...[ Price : $8.95]
FDA classifies as Class 1 a recall involving Hospiras Symbiq One- and Two-Channel Infuser touchscreen drug pumps.