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AcelRx Planning NDA Resubmission for Zalviso

[ Price : $8.95]

AcelRx Pharmaceuticals says it will resubmit early next year its NDA for pain drug Zalviso (sufentanil sublingual tablet system), ...

IoM Workshop Summary on Benefit/Risk Uncertainty

[ Price : $8.95]

The Institute of Medicine posts a summary report of its public workshops held earlier this year on advancing the development of mo...

FDA Reopens Comment Period on Social Media Guidances

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FDAs Office of Prescription Drug Promotion reopens for 30 days the comment period for two recent draft social media guidances.

FDA Safety Alert on Asthma Drug Xolair

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FDA issues a drug safety alert on Genentechs Xolair (omalizumab) due to a slightly elevated risk of cardiovascular and cerebrovasc...

OMB OKs Info Collection on Animal Drug User Fees

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on animal drug use...

FDA Sends Info Collection on GLP Regs to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on good laborator...

Guidance on FISH Test for Specimen Characterization

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Federal Register Notice: FDA releases a draft guidance: Content and Format for Abbreviated 510(k)s for Early Growth Response 1 Gen...

Panel to Discuss Alcon Labs IOL

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Federal Register Notice: FDAs Ophthalmic Devices Panel will meet 11/14 to discuss Alcon Labs PMA for an intraocular lens.

Public Meeting on Female Sexual Dysfunction

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Federal Register Notice: FDA plans a public meeting 10/27-28 on Female Sexual Interest/Arousal disorder.

FDA, NIH Win Award for Meningitis Vaccine Licensing

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FDA and the National Institutes of Health will receive an award for the years most outstanding intellectual property licensing dea...