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Dietary Supplement Ad Review Extended

[ Price : $8.95]

The Council for Responsible Nutrition and the National Advertising Review Council are extending for another five years their progr...

Pointe Scientific Reagent Recall is Class 1

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FDA designates a Pointe Scientific recall of liquid glucose hexokinase reagents as a Class 1 recall.

ICH Special Population Q&A Guidance Out

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FDA issues an ICH question-and-answer guidance on use of geriatric patients in clinical databases.

FDA Clears Onset Medical Catheter

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FDA clears an Onset Medical 510(k) for the SoloPath TransFemoral Endovascular Access Catheter.

Market Researcher Questions DTC Effectiveness

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Business Week says that a Verilogue study suggests that DTC ads are not effective in driving patients to ask doctors for specific ...

Boston Scientific Pays $296 Million to End Guidant Probe

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Boston Scientific says it will pay $296 million to resolve a Department of Justice probe into alleged problems with product adviso...

Comments Sought on E-Submissions for Drugs, Biologics

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Federal Register Notice: FDA seeks comments on electronic format labeling requirements for submitting drugs and biologic applicati...

Former FDA Chief of Staff to Lead FDLI

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Former FDA chief of staff Susan Winckler is appointed president of the Food and Drug law Institute.

Comments Sought on Bar Code Requirements

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Federal Register Notice: FDA seeks comments on drug and biologic bar code label requirements.

Guidance on IVD Tests for H1N1

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Federal Register Notice: FDA releases a guidance on emergency use authorization requests for in vitro diagnostic 2009 H1N1 tests.