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FDA Head Califf Discusses Improving Cardiovascular Outcomes

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FDA commissioner Robert Califf discusses improved research and technology development, combined with general advances in biologica...

FDA Issues Alexion with Form-483 After Inspection

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FDA issues Alexion Pharmaceutical a three-item Form-483 after inspecting its Smithfield, RI manufacturing facility.

Info on Commissioners Fellowship Program Sent to OMB

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

Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that nine drug products were not withdrawn for reasons of safety or effectiveness.

Guidance on Ulcerative Colitis Trial Endpoints

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Federal Register Notice: FDA releases a draft guidance: Ulcerative Colitis: Clinical Trial Endpoints.

Guidance on Submitting 510(k) for Device Software Change

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Federal Register Notice: FDA releases a draft guidance: Deciding When to Submit a 510(k) for a Software Change to an Existing Devi...

Guidance on 510(k)s for Changes to Existing Device

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Federal Register Notice: FDA releases a draft guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device.

Comments on OTC Drug User Fees Reopened

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Federal Register Notice: FDA reopens the comment period on the potential user-fee program for nonprescription drugs and plans a We...

CDRH Reaches Goal on Pre vs. Postmarket Device Data Collection

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Federal Register Notice: CDRH announces the completion of a goal to strike the right balance between premarket and postmarket data...

FDA Proposes Refusal of Insufficient Tobacco Product Applications

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Federal Register Proposed rule: FDA proposes to define when it would refuse to accept a deficient tobacco product submission.