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Transcripts Posted on FDA Medical Device 3-D Printing Workshop

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FDA posts transcripts from its 10/8-9 public workshop on Additive Manufacturing of Medical Devices: An Interactive Discussion on t...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Cell Vitals, Greiner Bio One Brasil Produtos, Jansen Enterprises, LLC dba Health...

Purdue Wants Updated Zolpidem BE Guidance

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Purdue Pharma asks FDA to update its draft bioequivalence guidance for zolpidem products with specific requirements for zolpidem b...

Class 1 Recall of Infant Head Supports

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FDA classifies as Class 1 a Childrens Medical Ventures (Philips Healthcare subsidiary) recall of all Gel-E Donut gel pillow and Sq...

Drug Supply Chain Enforcement Discretion Sought

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The Healthcare Distribution Management Association calls on FDA to provide more guidance or exercise enforcement discretion with t...

Guidance on SUPAC Manufacturing Equipment

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Federal Register Notice: FDA releases a guidance: SUPAC: Manufacturing Equipment Addendum.

Info on Supplement CGMPs Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on current good manufacturing practice for dietary suppl...

Guidance on Tracing Rx Drugs

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Federal Register Notice: FDA releases a draft guidance on standards for the interoperable exchange of information for tracing cert...

CDRH Guidance on Natural Rubber Latex Labeling Statements

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CDRH posts a final guidance on Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container...

FDA Complete Response on Avanir Migraine NDA

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FDA sends Avanir Pharmaceuticals a complete response letter on its NDA for AVP-825, a drug-device combination of low-dose sumatrip...