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Blood Products Panel to Meet

[ Price : $8.95]

Federal Register Notice: FDAs Blood Products Advisory Committee will meet 12/2-3 to hear data on the blood donor policy, the chiku...

Relypsa Files NDA for Patiromer

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Relypsa files an NDA for patiromer for oral suspension for treating hyperkalemia, a serious condition defined as abnormally elevat...

FDA Panel Backs Expanded Kalydeco Use in Cystic Fibrosis

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FDA advisory committee recommends expanded approval of Vertex Pharmaceuticals Kalydeco (ivacaftor) in people with cystic fibrosis ...

Drug Repackager Recalls Naproxen Cartons That Contain Ibuprofen

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Greensboro, NC-based Contract Packaging Resources recalls 11,640 boxes of Assured brand naproxen sodium tablets because some carto...

Hamburg Touts FDA Rare Disease Efforts

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FDA commissioner Margaret Hamburg says agency efforts to encourage development of new treatments for rare diseases are paying off.

Recalled Supplements Sell with Banned Ingredients: Study

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Researchers say that two-thirds of dietary supplements recalled by FDA for containing banned substances still contained those or o...

Court Says Some False Ad Claims Need FDA Expertise

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A California federal court says some Lanham Act false advertising cases require FDA expertise to resolve.

OMB OKs Info on Petitions for Exemption from Preemption

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Federal Register Notice: FDA submits a proposed collection of information on state petitions for exemption from preemption to the ...

Guidance on Developing Drugs for Migraine

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Federal Register Notice: FDA releases a draft guidance for industry entitled Migraine: Developing Drugs for Acute Treatment.

Workshop on Sentinel Initiative

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Federal Register Notice: FDA plans a public workshop 2/5/15: Seventh Annual Sentinel Initiative Public Workshop.