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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...

Reese Pharma Recalls Guaifenesin Lot

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Reese Pharmaceutical Company voluntarily recalls one lot of guaifenesin tablets sold under four brand names because the labels do ...

FDA Warns on Man Up Now Supplement

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FDA warns consumers to stop using Man Up Now capsules due to a Viagra-like ingredient that may cause dangerously low blood pressur...

FDA Accepts sNDA for Imaging Drug

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FDA accepts for review a Lantheus Medical Imaging supplemental NDA for Definity (perflutren lipid microsphere) injectable suspensi...

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...

FDA OKs Mylan Generic Anti-hypertensive

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FDA grants final approval to Mylan for its ANDA for nifedipine extended-release tablets to treat hypertension.