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Nominations Sought for Tobacco Panel

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Federal Register Notice: FDA requests nominations for members to serve on its Tobacco Products Scientific Advisory Committee.

CVM Warns on Transdermal Cat Device Risk

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CVM issues a warning on the risk of bone fractures with a Bioject transdermal vaccination system device for cats receiving Purevax...

DDMAC Cites Pfizer Web Page on 3 Product 'Misbrandings'

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DDMAC says Pfizer misbranded several drug products when it discussed their efficacy on a its Web site without providing any risk i...

Cytomedix Seeks Expanded Use for Angel Blood System

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Cytomedix submits a 510(k) for an expanded use for its Angel Whole Blood Separation System processing a bone marrow aspirate.

Public Citizen Supports IoM Call to Replace 510(k) Process

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Public Citizen endorses a recent Institute of Medicine (IoM) report that is critical of the agency''s 510(k) medical device cleara...

Fortune Magazine on MelaFinds 7-year Battle for FDA Approval

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Fortune magazine reports on Mela Sciences seven-year continuing effort to gain CDRH approval of its non-invasive, 98% effective di...

Small Correction in Notice on 510(k) Workshop

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Federal Register Notice: FDA corrects an outdated address in an 8/12 Federal Register notice announcing a public workshop on recom...

Group Backs PDUFA Patient Advocacy Proposals

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The National Health Council praises FDA and industry for coming to terms with three PDUFA proposals it put forth on behalf of the ...

FDA Approves Sagent Muscle Relaxant

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FDA approves Sagent Pharmaceuticals' 505(b)(2) NDA for orphenadrine citrate for injection, a skeletal muscle relaxant.

Reclast Labeling Changes on Kidney Failure

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FDA says labeling for Reclast has been updated to reflect the risk of kidney failure.