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FDA tells Kremers Urban Pharmaceuticals that it will need to conduct an additional bioequivalence study based on a recently issued...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America says FDA should develop a guidance document on conducting trials in biomarker...[ Price : $8.95]
Federal Register Notice: FDA invites comments on information collection requirements for firms intending to export FDA-regulated p...[ Price : $8.95]
FDA approves a Janssen Pharmaceuticals supplemental NDA for the once-monthly atypical antipsychotic Invega Sustenna (paliperidone ...[ Price : $8.95]
FDA clears a SQI Diagnostics 510(k) to market its proprietary Celiac Panel, an Ig plex Celiac DGP in vitro diagnostic test.[ Price : $8.95]
FDA approves an Allergan PMA to market two new styles, X and L, of the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-F...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on information collection in the Prescription Drug Marketing Act of 1987 Administrati...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on the procedure for dietary supplement manufacturers to submit to FDA information abo...