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FDA Clears Normative Database for Optovue

[ Price : $8.95]

FDA clears an Optovue 510(k) for its Normative Database for the RTVue OCT device used as a reference tool in assessing retina nerv...

Oncologists Debate Wisdom of Melanoma Trial Protocol

[ Price : $8.95]

A New York Times article describes the debate over whether new genetically engineered cancer treatments are best evaluated through...

Temple Sees No Conflicts in Marketed Drug Safety Reviews

[ Price : $8.95]

CDER deputy director for clinical science Bob Temple says during a television interview that there is nothing wrong with a drug re...

Avastin sBLA Review Extended

[ Price : $8.95]

Information submitted to FDA in a Genentech supplemental BLA for Avastin is deemed a major amendment by FDA and therefore the revi...

FDA Sets Biosimilars Meeting

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FDA reportedly will hold a two-day public hearing on issues and challenges associated with implementing a regulatory pathway for f...

FTC Wont Challenge Audit Programs

[ Price : $8.95]

The Federal Trade Commission says it appears that two Rx-360 supplier audit programs have a useful purpose and will not harm compe...

FDA Approves Medtronic Integrity Stent System

[ Price : $8.95]

FDA approves a Medtronic PMA for its continuous sinusoid technology Integrity Coronary Stent System.

FDA Panel Back Blood Thinner

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FDA's Cardiovascular and Renal Drugs Advisory Committee votes unanimously to recommend approval of Boehringer Ingelheim's blood th...

Advisors Back New Vivitrol Indication

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FDAs Psychopharmacologic Drugs Advisory Committee recommends approval of a new indication for Alkermes Vivitrol to treat opioid de...

FDA Accepts Aricept Patch for Review

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FDA accepts for review an Eisai NDA for the Aricept Patch (donepezil transdermal system), indicated for treating mild, moderate an...