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OMB OKs Info Collection on Device Informed Consent

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on devices and exception from ge...

FDA Submits Collection of Info on NDAs to OMB

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

FDA Issues Emergency Use Authorization for Ebola Diagnostic

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Federal Register Notice: FDA issues an Emergency Use Authorization for an in vitro diagnostic device for detecting Ebola.

Guidance on ANDAs and Justification of Impurity Limits

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Federal Register Notice: FDA is making available a draft guidance for industry entitled ANDA Submissions Refuse to Receive for La...

Panel to Discuss Daiichi Sankyo NDA for Preventing Stroke/Embolism

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 10/30 to discuss a Daiichi Sankyo NDA fo...

Public Workshop Scheduled on E-Cigarettes

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Federal Register Notice: FDAs Center for Tobacco Products will hold a public workshop 12/10-11 to discuss electronic cigarettes.

Soligenix, FDA Reach Agreement on Lymphoma Trial

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Soligenix reaches an agreement with FDA on the design of a Phase 3 clinical trial of its synthetic hypericin product for treating ...

QS, MDR Problems Found at Advanced MicroVas

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FDAs Dallas District Office warns Advanced MicroVas of quality system, medical device reporting, and other regulation violations i...

Court Rules for Catheter Connections in Patent Case

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The Utah federal district court says Ivera Medical violated a preliminary injunction barring it from selling Curos Tips that infri...

ANDA Refuse-to-Receive Standards Guidance

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FDA issues a guidance to help applicants submitting ANDAs to understand what deficiencies may lead the agency to refuse to receive...