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FDA Transparency Has a Long Way to Go

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FDA Webview Washington editor David McFarland examines FDAs refusal to release a letter to Congress on drug reimportation concerns...

CGMPs Regs Released for PET Drugs

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Federal Register Final rule: FDA issues current good manufacturing practice regulations for approved positron emission tomography ...

More Attorneys for FDA: Wasteful Duplication or Something Else?

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Consulting editor John Scharmann reviews the growing number of attorneys being hired by diverse FDA offices for purposes already s...

Advisors Back Gileads Aztreonam Safety, Efficacy

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FDAs Anti-infective Drugs Advisory Committee votes 15-2 to recommend that Gileads aztreonam is safe and effective in treating lung...

Repligen Mixed Results for MRI-enhancer

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Repligen reports mixed results from a Phase 3 clinical trial evaluating RG1068, a synthetic human secretin intended to improve mag...

Protalix Bio Submits NDA on Gauchers Therapy

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Protalix Biotherapeutics submits an NDA for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for treati...

Docket on Tobacco Retailer Training Established

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Federal Register Notice: FDA establishes a public docket to obtain suggestions on elements for an approved tobacco retailer traini...

Guidance on Patient-Reported Outcomes

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Federal Register Notice: FDA releases a guidance, Patient-Reported Outcome Measures Use in Medical Product Development to Support ...

FDA Releases Final Rule on PET Drugs

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An FDA final rule will require producers of PET drugs to submit NDAs or ANDAs for their drugs starting in two years.

Does Administration Favor Rx Drug Imports?

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The Obama administration sends mixed signals on whether it supports legislation to permit drug importation.