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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 ...

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...

Teva Petitions FDA to Block Generic Copaxone Competition

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Teva Pharmaceutical Industries files a citizen petition seeking to block FDA approval of generic copies of its multiple sclerosis ...

FDA OKs Medtronic's Diabetes Management Software

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FDA approves Medtronic's CareLink Pro 3.0 Therapy Management Software, a software program that offers advanced decision support to...

FDA's Temple Sees Notable Changes with Drug Safety

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CDER deputy director for clinical science Bob Temple says the most conspicuous changes at the Center over the past few years are t...