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FDA Proposes End to CFCs in Metered-dose Inhalers

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FDA proposes eliminating CFCs in OTC epinephrine metered-dose inhalers.

Advisors Recommend Repel-CV for Pediatric Use

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FDAs Circulatory System Devices Advisory Panel recommends FDA approve SyntheMeds Repel-CV for pediatric use.

FDA Sends Info on Device QSRs to OMB

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Federal Register Notice: FDA submits a proposed collection of information on Quality System Regulations for medical devices.

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...

People Trust FDA, Unsure if it Performs Well

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An American University survey says consumers trust FDA more than any other organization on prescription drug issues but arent sure...

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.