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Risk Documents Key in Device Design: Column

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Retired Ethicon quality engineer Eric Hinrichs says medical device project design teams must document all risk assessments and how...

McKinsey FDA Contract Under Fire at Hearing

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A House Committee on Oversight and Reform hearing sharply criticizes consulting firm McKinsey and Co. for its role in advising Pur...

Current Merger Enforcement is Working: PhRMA

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PhRMA cites FDA statistics to support its position that the Federal Trade Commission and Department of Justice dont need new ways ...

Pfizer Recalls 5 Accupril Lots

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FDA says Pfizer is recalling five lots of Accupril due to the presence of a nitrosamine above the acceptable daily level.

FDA Pushes Congress for Catalyst Decision Fix

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FDA says it is interested in working with Congress to find a legislative solution, most likely a bill that would be added to the u...

Info Collection Revision on Expanded Access Form

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Federal Register notice: FDA sends to OMB an information collection revision entitled Expanded Access to Investigational Drugs for...

Janssen Sues to Block Counterfeit HIV Meds

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Janssen asks a New York federal court to stop several drug wholesalers from selling counterfeit versions of the companys HIV drugs...

Postmarketing Safety Electronic Submission Guidance

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FDA publishes a guidance with general information on the electronic submission of specified postmarketing safety reports to CBER a...

Medtronic EMG Tube Airway Risk Evaluated

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FDA says it is evaluating reports of an increased risk of airway obstruction associated with two Medtronic silicone-based EMG endo...

FDA Seeks Industry Rep for Pediatric Panel

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Federal Register notice: FDA seeks industry organizations interested in participating in selecting a nonvoting industry representa...