[ 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.[ Price : $8.95]
A new report from Rep. Edward Markey (D-MA) calls for more FDA oversight authority over pharmacy compounding.[ Price : $8.95]
FDA grants priority review to Bayer HealthCare for its NDA for Stivarga (regorafenib) tablets, indicated to treat patients with me...