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Vasogen Plans NDA on Celcade for Heart Failure

[ Price : $8.95]

Vasogen Inc. plans a pre-NDA meeting with FDA after promising data is released from its 2,400-patient ACCLAIM trial of Celacade in...

FDA Withdraws Blood Vessel Organ Rule

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Federal Register Direct final rule: FDA withdraws a direct final rule on amending regulations to consider as part of an organ thos...

GSKs Marketing Expenses at Issue in $3.1 bil IRS Settlement

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IRS says the way GlaxoSmithKline accounted for marketing and advertising expenses in the U.S. was a central area of contention in ...

Now Boasting 72 Members, FDA Alliance Targets Hill

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The newly formed FDA Alliance announces it has 72 members and is recruiting a lobbyist to help it secure increased congressional f...

FDA OKs Lupins Generic Rocephin

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FDA approves a Lupin Pharmaceuticals ANDA for a generic copy of Roches Rocephin.

Stanford Bans All Industry Gifts in New Policy

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Medical products sales reps face tight restrictions at Stanford University Medical Center after the medical school adopts new conf...

FDA, NCI Sign MOU on Clinical Investigator Info

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Federal Register Notice: FDA and the National Cancer Institute sign a memorandum of understanding to develop an electronic Federal...

Abtox Chief Gets 10 years; Tough FDA Warning in 2003 Affirmed

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Abtox principal Ross Caputo gets 10 years imprisonment and his vice president Robert Riley six years for selling illegal hospital ...

FDA Lands Pediatric Ethicist Expert Nelson

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Childrens Hospital of Philadelphia anesthesiology and critical care associate professor Robert M. Nelson joins FDAs Office of Pedi...

Research Shows DTC Drives Patients to Their Doctors

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New research on direct-to-consumer advertising finds the ads provide a public health benefit by pushing patients to see their phys...