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Incredulous Congressmen Want Outsourcing Info

[ Price : $8.95]

Reps. Dingell and Stupak ask FDA commissioner Andrew von Eschenbach for detailed information on plans to outsource 332 FDA jobs.

Baxter Drops Brevibloc Concentrate on Safety Concerns

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Baxter Healthcare says it is going to stop making Brevibloc concentrate 250 mg/mL, 10 mL ampuls due to the potential for medicatio...

Alzhemed Treatment Effect Unclear

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Neurochem says its Phase 3 trial of Alzhemed did not demonstrate a statistically significant difference in primary endpoints over ...

FDA Clears Smith & Nephew Knee Systems

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FDA clears three Smith & Nephew 510(k)s for the Journey Bi-Cruciate Stabilized Knee System, the Genesis II Total Knee System and t...

Genentech Resubmits sBLA on Avastin

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Genentech resubmits a supplemental BLA for Avastin, seeking an indication for combination use with paclitaxel chemotherapy in trea...

FDA OKs Tevas Generic Famvir

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FDA approves a Teva Pharmaceutical Industries ANDA for a generic version of Novartis' genital herpes drug Famvir.

Guidance on Lookback for Hepatitis C Virus

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Federal Register Notice: FDA releases a guidance on lookback requirements for hepatitis C virus.

Comments Sought on Drug Registration/Listing

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Federal Register Notice: FDA seeks comments on requirements for drug producer registration and listing of drugs in commercial dis...

FDA Requires Identifying System with Evidence of HCV

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Federal Register Final rule: FDA requires blood establishments to follow a system for identifying blood and blood components donat...

HCV Lookback Guidance Out

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FDA issues a guidance to help blood establishments, hospitals, and other consignees follow hepatitis C virus lookback regulations.