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Advanced Bionics Recalls Cochlear Implants

[ Price : $8.95]

Advanced Bionics notifies FDA that it is voluntarily recalling its HiRes 90K cochlear implant devices due to two reported cases of...

FDA, Industry Move Forward on Mid-review Communications

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FDA and industry discuss longer user fee review times to allow for a mid-review communication for feedback from reviewers on the s...

FDA Clears Object Researchs ORS Visual Software

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FDA clears an Object Research Systems 510(k) for its Advanced Visualization software, ORS Visual.

FDA Webview Closed for Thanksgiving Break

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FDA Webview closes 11/25-26 in observance of the annual Thanksgiving holiday break.

FDA Approves Armpit Testosterone Replacement

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FDA approves an Eli Lilly and Acrux NDA for Axiron (testosterone) topical solution applied to the armpit for replacement therapy i...

Genzyme Says it Makes Milestone Progress on Consent Decree

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Genzyme says it has met the first milestone under its consent decree with FDA over GMP issues at its Allston, MA manufacturing fac...

FDA Posts Inspection Findings on Gilead California Plant

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FDA field investigators cite aseptic processing deficiencies at a Gilead San Dimas, CA manufacturing plant.

Micromedics Recalls 3 Devices Over Sterility

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Micromedics recalls its Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes because the products a...

Quality System Violations Found at Eastern Cranial

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FDAs Baltimore District Office warns Eastern Cranial on Quality System and other violations associated with its KidCap Cranial Mol...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Eastern Cranial Affiliates, Eminent Spine, Fasprin Health/Nobel Laboratories, HS...