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NSAIDs Pass Muster Again at EMEA Safety Evaluation

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Another EMEA safety evaluation of marketed NSAIDs finds an acceptable risk-benefit profile for the pain killers.

Guidance Out on PMA Annual Reports

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FDA issues a guidance on information to be included in required PMA annual reports.

Slight Drop in Global Drug Market Growth Seen

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IMS Health predicts a slight slowing in worldwide drug market growth in 2007.

FDA Clears Protein Polymer PVA Foan 510(k)

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FDA clears a Protein Polymer Technologies 510(k) to market its PVA foam embolization convenience kits for peripheral vascular indi...

2nd Judge Rejects FDA Labeling Preamble on Preemption

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A second judge rejects FDAs controversial preamble to its new drug labeling regulations asserting preemption over state law in fai...

Beitz Named ODE III Director

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CDER names Office of Drug Evaluation III acting director Julie Beitz as permanent director.

Michigan Product Liability Bill Under Attack

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Two Michigan attorneys defend that states drug product liability law against challenges from trial lawyers.

New Warning on Effexor Overdosage Potential

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A new warning on Wyeths antidepressant Effexor cautions healthcare professionals about an overdose potential associated with the d...

Troy Defends FDA Preemption Position

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Former FDA chief counsel Dan Troy explains the benefits from FDAs defense of its preemption of state failure-to-warn laws.

Drug Recalls Continue Their Sharp Upswing

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CDER acting director of compliance Joseph Famulare reports that a total of 367 drug product recalls have been reported to FDA so f...