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Cephalon Settles Off-Label Actiq Claims

[ Price : $8.95]

Cephalon says it will pay $425 million and agree to one misdemeanor violation to resolve a federal probe of its Actiq marketing pr...

New Sprycel Labeling Approved

[ Price : $8.95]

FDA approves a lower recommended starting dose for Bristol-Myers Squibbs Sprycel for patients with chronic myeloid leukemia who ar...

FDA Reports Shortage of Merck Infant Vaccine

[ Price : $8.95]

FDA says that Merck is experiencing product shortages involving PedvaxHIB (Haemophilus B conjugate vaccine) due to manufacturing i...

FDA Clears Baxters Needleless IV Connector

[ Price : $8.95]

FDA clears a Baxter Healthcare 510(k) for the V-Link Luer-activated device, a needleless IV connector containing an antimicrobial ...

Trial Protocol Cleared on Abuse-Deterrent Oxycodone

[ Price : $8.95]

FDA and Elite Pharmaceuticals agree on the design of a Phase 3 trial involving ELI-216, the companys abuse deterrent oxycodone pro...

FDA Approves New Crestor Indication

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FDA approves a new indication for AstraZenecas Crestor as a diet adjunct to slow atherosclerosis in patients with high cholesterol...

Guidance on Drug Development for COPD

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Federal Register Notice: FDA releases a draft guidance on developing drugs for chronic obstructive pulmonary disease.

Comments Sought on Device Fellowship Program

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Federal Register Notice: FDA seeks comments on an application for participating in the Medical Device Fellowship Program.

Info on Orphan Products Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the joint FDA/EMEA application form on orphan product...

Panel to Discuss Permanent Sterilization Method

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Federal Register Notice: FDAs Obstetric and Gynecology Devices Panel will meet 12/13-14 to discuss a Cytyc Surgical Products PMA f...