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Quality, Reporting Problems Found at Ophthalmic Technologies

[ Price : $8.95]

CDRH warns Canadas Ophthalmic Technologies for QS and MDR violations and says an Import Alert has been issued for its devices.

Glaxo Resolves Injectable Argatroban Supply Shortage

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FDA reports that GlaxoSmithKline has resumed normal supply shipments of argatroban for injection that had been in short supply due...

Subpoena Threatened in PR-gate Probe

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Reps. John Dingell and Bart Stupak say FDA has not delivered all records and materials requested for a committee probe into a cont...

FDA Extends Review of Wilmingtons Metazolv NDA

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FDA extends by three months its review of a Wilmington Pharmaceuticals NDA for Metozolv orally disintegrating tablets.

Advisors Say Embeda Abuse Plan Could Help

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FDA advisors say that Alpharma abuse-prevention plans for Embeda could deter some, but not all, potential abusers.

FDA OKs Eisai NDA for Seizure Drug

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FDA approves an Eisai Corp. NDA for Banzel (rufinamide), indicated as adjunctive treatment of seizures associated with Lennox-Gast...

Altus Plans on 2009 NDA for Trizytek

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Altus Pharmaceuticals says it plans to submit an NDA for Trizytek (liprotamase) during the first-half of 2009.

FDA Reports Continuing Shortage with Zostavax

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FDA reports that Merck continues to experience shipping delays for Zostavax (zoster vaccine live).

FDA Tentatively OKs Mylans Generic Effexor

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FDA tentatively approves a Mylan ANDA for a generic copy of Wyeths Effexor XR.

FDA Posts Lifecycle Process Validation Guide

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FDA posts a long-awaited drug manufacturing process validation draft guidance entitled Process Validation: General Principles and ...