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Hamburg Defends Zohydro Actions

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FDA commissioner Margaret Hamburg defends the agencys handling of Zohydro, as USA Today urges that the approval be reconsidered.

Studies Query Data for 510(k) OKs, Post Approval Studies

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Researchers say FDA needs to do a better job making sure scientific evidence to support 510(k) clearances is publicly available, w...

CDER OKs Reminder-like Posts for Boxed Warning Drugs

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CDER Office of Prescription Drug Promotion special assistant to the director Jean-Ah Kang says firms can use reminder-like promoti...

FDA Awards $19 Million in Rare Disease Product Develoment Grants

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FDA awards 15 grants totaling more than $19 million to stimulate drug, medical device, and biological product development for pati...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites ArjoHuntleigh, CalComp Nutrition, dōTERRA International, Express Diagnostic...

Discussion Paper on Brain-Computer Interface Devices

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FDA releases a discussion paper in preparation for its Brain-Computer Interface (BCI) Devices for Patients with Paralysis and Ampu...

FDA Draft Guidance on Lab-Developed Test Framework

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FDA posts a draft guidance on its Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) that describes a risk-ba...

Collection of Info on Drug Communications Sent to OMB

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Federal Register Notice: FDA submits a proposed collection information on data to support drug product communications to the Offic...

CGMP Problems Seen in Valeant Inspection

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FDAs New Jersey District Office warns Valeant Pharmaceuticals about Quality System Regulation violations in its production of Scul...

Social Media Guidance Problematic: Hale Advisors

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Hale Advisors principal Zoe Dunn writes that FDAs Guidance on Social Media Platforms with Character Space Limitations undermines p...