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Genentech Gets Full Approval for Avastin in Glioblastoma Patients

[ Price : $8.95]

FDA grants full approval for Genentechs Avastin (bevacizumab) for treating adults with glioblastoma that progressed following prio...

FDA Comment Period Extended on Reducing Regulation Burdens

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Federal Register notice: FDA extends the comment period on a 9/8 notice seeking input on existing regulations and related paperwor...

Insys Therapeutics NDA for Sublingual Spray Pain Drug

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FDA accepts for review an Insys Therapeutics NDA for what it calls a novel formulation of buprenorphine as a sublingual spray for ...

SCOTUS Wants Governments View on Fosamax Case

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The Supreme Court asks the Solicitor General to provide the governments view on Mercks appeal of a 3rd Circuit decision involving ...

MDR, QS Violations at Hand Biomechanics

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FDA warns Hand Biomechanics about Medical Device Reporting and Quality System Regulation violations in its manufacturing of bone f...

Breakthrough, Fast Track Programs Cut Approval Times: Study

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The Los Angeles Times says researchers have found that the FDA breakthrough designation and fast track programs are particularly e...

Find Ways to Encourage Generic Drug New Uses: Article

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Three researchers could for steps outside the patent system to encourage discover of new uses for generic drugs.

GCMP Issues at Hangzhou Facecare Cosmetics

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FDA warns Chinas Hangzhou Facecare Cosmetics Co. about CGMP violations in its production of finished pharmaceuticals as a contract...

FDA Performance Board Members Announced

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Federal Register notice: FDA announces the names of the members who will serve on its Performance Review Board.

Required Notice on Biosimilar Patent Infringement Suit

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Federal Register notice: FDA provides notice that an applicant for a proposed biosimilar product notified the agency that a patent...