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Mammography Panel to Meet

[ Price : $8.95]

Federal Register Notice: FDAs National Mammography Quality Assurance Advisory Committee will meet 1/25/10 to discuss recent guidan...

Panel to Discuss Lung & Breast Cancer sNDAs

[ Price : $8.95]

Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 12/16 to discuss GlaxoSmithKlines supplemental NDA for ...

Workshop on Thermal Effects of Radio Frequency

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 1/11-12/10 on the thermal aspects of radio frequency exposure.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Abbott Molecular, Arnold Tuber, Dynamic Nutritional, Anthony Dallas, and Eisai.

Kryptonite Bone Cement Cleared by FDA

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FDA clears a Doctors Research Group 510(k) for the Kryptonite Bone Cement for cranioplasty applications.

Advisors Asked About Spiriva Efficacy, Safety Data

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FDA asks the Pulmonary-Allergy Drugs Advisory Committee whether clinical trial data support a claim that Pfizer/Boehringer Ingelhe...

FDA Rejects NDA for Neuromed Pain Drug

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FDA tells Neuromed that it cannot approve its pending NDA for Exalgo (hydromorphone HCl) extended release tablets, indicated for m...

Researchers Mull Niacin/Ezetimibe Trial Data

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Researchers from Johns Hopkins say that just-released clinical trial data showing that cholesterol-lowering niacin was superior to...

Dacogen Patient Profile Card Misleading: DDMAC

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DDMAC says that a patient profile card for Eisais Dacogen overstates the drugs efficacy and omits important risk information and m...

Advice Sought on Prevnar 13 Efficacy

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FDA asks its Vaccines and Related Biological Products Advisory Committee to comment on the safety and effectiveness of Pfizers Pre...