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Drug Industry Urges Consistent Drug Labeling eSubmissions

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PhRMA says FDA new drug reviewers need to be more consistent and not request paper copies of electronic labeling submissions or su...

FDA Transfers Live Cell Wound Care Products to CBER

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Federal Register Notice: FDA transfers oversight responsibilities for certain wound care products containing live cells from CDRH ...

Info on Tobacco Health Document Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on tobacco health document submission to the Office of M...

Guidance on Radio Frequency Wireless in Devices

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Federal Register Notice: FDA releases a guidance: Radio Frequency Wireless Technology in Medical Devices.

Workshop on Gastroenterology Therapeutics

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Federal Register Notice: CDER will co-sponsor a public workshop 10/21-22 on gastroenterology regulatory endpoints and the advancem...

Did FDA Drop the Ball with Texas Pharmacy Compounder?

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Public Citizen says FDA should be investigated for dropping the ball after a March inspection uncovered sterility concerns at Texa...

Forest, Almirall Delay COPD Combo Drug Submission

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Forest Labs and Almirall say they will delay an NDA submission for the combination of aclidinium bromide and formoterol fumarate f...

Nova Biomedical Recalls Glucose Test Strips

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Nova Biomedical recalls its Nova Max Glucose Test Strips because some strips may report false, abnormally high glucose readings.

Hospira Class 1 Recall Blood Administration Sets

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FDA classifies as Class 1 a Hospira recall involving its intravascular administration sets due to puncture concerns.

A New FDA Wrinkle? Just Dont Approve Nasty Products

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Washington commentator Bob Steeves says FDA may be deliberately refusing to approve any new tobacco products, thereby choking off ...