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FDA Sees Need to Improve NDC Directory

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FDA says it generally agrees with an HHS Inspector General recommendation that it do a better job of ensuring completeness and acc...

Sanofi Pasteur Trial Begins with C-diff Vaccine

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Sanofi Pasteur starts a Phase 2 clinical study involving a vaccine for primary prevention of Clostridium difficile infection.

Spectrum Pharma Resubmits sNDA for Fusilev

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FDA accepts for review a Spectrum Pharmaceuticals supplemental NDA re-submission for Fusilev (levoleucovorin) for injection for tr...

Advanced Bionics Recalls Cochlear Implants

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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...

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.