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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...

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.

Watson Gelnique Promo in the 'Crapper:' FDA

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FDA cites as misleading a Watson Pharmaceuticals public bathroom promo that was used to promote Gelnique (oxybutynin chloride).

Does FDA Topsides Lack of Transparency Fuel Public Distrust?

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Consulting editor John Scharmann reviews the FDA leaderships increasing lack of transparency and suggests it may be a political co...

Review Period Set for Sanofi-Aventis Multaq

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Federal Register Notice: FDA determines the regulatory review period set for Sanofi-Aventis Multaq for the purpose of patent exten...