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Advanced Bionics notifies FDA that it is voluntarily recalling its HiRes 90K cochlear implant devices due to two reported cases of...[ Price : $8.95]
FDA and industry discuss longer user fee review times to allow for a mid-review communication for feedback from reviewers on the s...[ Price : $8.95]
FDA clears an Object Research Systems 510(k) for its Advanced Visualization software, ORS Visual.[ Price : $8.95]
FDA Webview closes 11/25-26 in observance of the annual Thanksgiving holiday break.[ Price : $8.95]
FDA approves an Eli Lilly and Acrux NDA for Axiron (testosterone) topical solution applied to the armpit for replacement therapy i...[ Price : $8.95]
Genzyme says it has met the first milestone under its consent decree with FDA over GMP issues at its Allston, MA manufacturing fac...[ Price : $8.95]
FDA field investigators cite aseptic processing deficiencies at a Gilead San Dimas, CA manufacturing plant.[ Price : $8.95]
Micromedics recalls its Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes because the products a...