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Guidance on User Fee Waivers

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Federal Register Notice: FDA releases a guidance on requests for user fee waivers and reductions or refunds.

No FDA Ruling on Blood Clots Associated with Pill

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FDA says it has not yet reached a conclusion about the potential increase blood clot risk associated with the use of drospirenone-...

FDA Mulls Help on Antibiotics Development: Woodcock

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CDER director Janet Woodcock says the agency is considering options to ease the development path for antibiotics.

Embattled MelaFind Device Gains 'Approvable' Letter

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FDA sends a PMA approvable letter to Mela Sciences for its non-invasive melanoma diagnostic scanner, MelaFind,which has been in li...

Info on Application Certifications Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a certification to accompany drug, biologic and devic...

Info on Accredited Persons Inspections Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on inspection requests under the accredited persons progra...

Panel to Discuss Non-Standardized Allergen Extracts

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Federal Register Notice: FDAs Allergenic Products Advisory Committee will meet 10/25 to hear CBERs review of literature on the use...

Panel to Discuss Community-Acquired Bacterial Pneumonia

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Federal Register Notice: FDAs Anti-Infective Drugs will meet 11/3 to discuss clinical trial design for developing antibacterials t...

Panel to Discuss Antibacterials for Hospital-Acquired Pneumonia

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 11/4 to discuss clinical trial design for antibact...

Panel to Discuss Salix Xifaxan for IBS

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Federal Register Notice: FDAs Gastrointestinal Drugs Advisory Committee will meet 11/16 to discuss the design of clinical trials e...