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Neuralstem Files an IND for Spinal Cord Stem Cells Trial

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Neuralstem, Inc. files an IND with FDA to begin a Phase 1 safety trial to test its spinal cord stem cells in chronic spinal cord i...

FDA Clears Haldor Instrument/Sponge Locator

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FDA clears Haldor Advanced Technologies ORLocate automated system used to track instruments and sponges during surgical procedures...

CRO Warned on Preclinical GLP Violations

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FDA sends a Warning Letter to preclinical contract research organization SNBL USA after inspections in 2008 and 2009 found repeate...

FDAs Fear of Information Drives its Transparency Phobia

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FDA Webview editor Jim Dickinson sees revelatory insights about FDAs deepening secretiveness in an exchange between reporters and ...

FDA Approves Actelion's Veletri Brand Name

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FDA approves an Actelion Pharmaceuticals submission to add the brand name Veletri to the company's approved epoprostenol for injec...

FDA Receives ANDA for Generic Copy of Revlimid

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FDA says it has received an ANDA from and undisclosed applicant to market a generic copy of Celgene's Revlimid (lenalidomide) 25 m...

CBER Issues Lot Distribution Electronic Submission Guidance

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CBER publishes a guidance recommending ways in which biologics manufacturers can electronically submit lot distribution reports.

FDA Proposes PMA or PDP for 4 Devices

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Federal Register Proposed rule: FDA proposes to require a PMA or notice of completion of a PDP for four Class 3 preamendments devi...

Avandia No Riskier Than Actos: Study

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A new study suggests Avandia has no different cardiovascular risks than Takeda's Actos (pioglitazone).

Pharming Group Plans BLA for Rhucin

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Pharming Group plans to submit a BLA by the end of the year for Rhucin, indicated for treating acute angioedema attacks in patient...