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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites BioCheck Inc. Eagle Health Supplies, Hill Dermaceuticals, and Soma Labs.

New FDA Guidance on Co-developed Combination Drugs

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A new FDA guidance provides the agency's current thinking for sponsors intending to develop a combination product involving two or...

FDA, Industry Differ on Non-binding Advice Process

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FDA says an industry PDUFA 5 proposal for brief teleconferences to clarify issues for emerging drug development programs would be ...

BioCheck Marketing Products for Unapproved Use: FDA

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FDAs San Francisco District Office warns BioCheck it is selling in vitro reagents for unapproved uses.

Advocacy Group Says FDA Backs its Antimicrobial Use Warning

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The Union of Concerned Scientists says an unannounced FDA report on livestock antimicrobial use supports its 2001 contention that ...

High Court to Decide Generic Drug Preemption

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The U.S. Supreme Court agrees to hear consolidated appeals involving generic drug preemption.

FDA Clears Chest Tube Clearing System

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FDA clears a Clear Catheter Systems 510(k) for its innovative PleuraFlow Active Tube Clearance System.

FDAs Virtual Iron Curtain Defeats the Right to Know

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FDA Webview editor Jim Dickinson analyzes the effective defeat of the news medias trust but verify constitutional duty to keep fed...

Comments Sought on Color Additives Info for Drugs, Devices

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Federal Register Notice: FDA seeks comments on the information collection provisions of regulations on batch certification of colo...

FDA Seeks Notification on MDUFA Meetings

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Federal Register Notice: FDA requests that groups intending to participate in consultation meetings on reauthorizing the Medical D...