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FDA, MediciNova Hold Bedoradrine Phase 2 Meeting

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FDA and MediciNova hold an end-of-Phase 2 meeting on the companys bedoradrine (MN-221) for treating asthma and COPD acute exacerba...

Pre-submission Medical Device Meeting Guidance Praised

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Stakeholders say they support FDAs efforts in a draft guidance on medical device pre-submission meetings.

Inspectors Find Quality Problems at Global Medical

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FDAs Kansas City District Office warns Global Medical Products about Quality System Regulation violations in its production of res...

Confidence, Inc., Drugs, Supplements Seized

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U.S. marshals seize one drug and several dietary supplements marketed by Confidence, Inc.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Advanced Nutritional Technology, Garlic Wise, Global Medical Holdings, Primus Me...

FDA, Mylan Seek Stay on Pioglitazone Shared Exclusivity

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FDA joins a Mylan expedited motion seeking a stay on a 10/22 Washington federal court order to approve a Watson Laboratories ANDA ...

Research Shows Medtronic Resolute Stent Successes

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Medtronic says it has applied to FDA for marketing approval for its 38mm Resolute drug-eluting stent for use in treating long lesi...

FDA Avoids Mission in Meningitis Drug Compounding Tragedy

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As Massachusetts belatedly steps into a void left by FDA in the regulation of high-volume drug compounders, FDA Webview editor Jim...

Communication Breakdown? CDER Liaison Staff Will Help

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A CDER official discusses a new PDUFA 5 program that establishes liaison staff for drug sponsors who have requested information fr...

CDER Improves Backlog of Post-marketing Commitments

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CDER says that 14% of outstanding postmarketing requirements and postmarketing commitments are considered delayed, compared with 1...