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Lawmakers Push FDA for ALS Therapies

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A group of bipartisan lawmakers write FDA asking that it do more to help get therapies approved for treating amyotrophic lateral s...

FDA Reform Needed to Address Lack of Urgency: Forbes

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Pacific Research Institute president Sally Pipes says FDAs foot dragging in recommending updated Covid-19 vaccines last month and ...

FDA Revoking Methods of Analysis Regulation

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Federal Register proposed rule: FDA proposes to revoke its methods of analysis regulation (21 CFR 2.19) that describes policy to u...

FDA Revokes EUA on Covid Detection Kit

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Federal Register notice: FDA revokes the emergency use authorization issued to ScienCell Research Laboratories for its ScienCell S...

Guide on Instructions for Use Patient Labeling

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Federal Register notice: FDA makes available a final guidance entitled Instructions for UsePatient Labeling for Human Prescription...

Provepharm NDA for Bludigo Approved

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FDA approves a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid...

Senator Burr Introduces 'Clean' Version of User Fee Bill

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Senator Richard Burr (R-NC) introduces a "watered-down" and less controversial FDA user fee reauthorization bill that is intended ...

Pfizers Xalkori OKd for Myofibroblastic Tumors

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FDA approves a Pfizer supplemental NDA for Xalkori (crizotinib) for adult and pediatric patients with unresectable, recurrent, or ...

Court Takes Action Against Edge Pharm

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A federal court has permanently enjoined a Colchester, VT, compounding pharmacy from distributing drugs unless they are manufactur...

Eko Murmur Smart Stethoscope Software Cleared

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FDA clears an Eko 510(k) for its Eko Murmur Analysis Software for use in its smart stethoscope for detecting and characterizing mu...