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Pharmaceutical GMP Workshops Slated

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Federal Register Notice: FDA plans a series of educational workshops on quality pharmaceutical production under current good manuf...

FDA Seeks End to Epinephrine Essential-Use in MDIs

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Federal Register Proposed rule: FDA proposes to remove the essential-use designation for epinephrine used in oral pressurized mete...

Senate Passes FDA Bill After Opposition Lifted

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The Senate passes unanimously the FDA Amendments Act 9/20 after Richard Burr (R-NC) drops a hold he'd placed on it in opposition t...

Purdue Settles OxyContin Marketing Case

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Purdue Pharma pays $160 million to the federal government and several states to settle charges of improperly marketing OxyContin o...

Broken Government Symptoms May be Seen at FDA

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FDA Webview editor Jim Dickinson sees symptoms at FDA of a contention in John W. Deans latest book, Broken Government, that Republ...

FDA Clears Retinal Risk Assessment System

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FDA clears a Digital Healthcare 510(k) for the Retasure retinal risk assessment system and its IP technology platform.

FDA Names Cot to Head Orphan Products

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FDA selects CDC Rwanda country director Timothy Cot as the new director of the agencys Office of Orphan Products Development.

House Passes FDA Revitalization Act

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The House of Representatives passes the FDA Revitalization Act after a House-Senate conference adopts a compromise version of diff...

Drug Ad Violations Up, Biologics Down

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FDA says enforcement trends for violations of advertising/promotion regulations indicate actions against drug advertisers have ris...

FDA Seeks to Boost Consumer Ad Comprehension

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DDMAC calls marketers attention to FDA-funded research projects designed to improve consumer understanding of print and television...