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Voraxaze Web Page Promotes Drug Before Approval

[ Price : $8.95]

CDER sends an untitled letter to Protherics over its Web page promoting Voraxaze before it has been approved by FDA.

Quality Problems in Chinese Device Facility

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CDRH warns Onbo Electronics of multiple quality violations in its Shenzhen, China, medical device manufacturing facility.

FDA Panel Backs Takeda Gout Drug

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FDAs Arthritis Drugs Advisory Committee recommends approval of a Takeda NDA for Uloric (febuxostat), indicated for treating hyperu...

Japanese Device Plant Has Quality Problems

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CDRH warns Fuji System Corp. on quality problems at its Tokyo balloon catheter manufacturing facility.

Study 14 Drugs Off-label Use: Researchers

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Researchers suggest 14 drugs that need to be studied for heavy off-label use without sufficient scientific evidence of effectivene...

FDA Looking at Skin Reactions to Epilepsy Drugs

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FDA is looking into a potential increased risk of serious skin reactions in some Asian patients taking phenytoin or fosphenytoin t...

Kindness Debarred

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Federal Register Notice: FDA issues an order to permanently debar George Kindness from providing services to anyone with an approv...

Page Debarred

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Federal Register Notice: FDA issues an order permanently debarring Dr. Roy Page from providing services to anyone with an approved...

ThermoGenesis Expands Bagset Recall

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ThermoGenesis expands a medical device removal to include six lots of its AXP Processing Bagset.

FDA Seeking Diabetes Drug Safety Data

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TheStreet.com says FDA is asking drug companies to provide cardiac safety data for all diabetes drugs now in clinical trials.