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14 Products on Latest FDA Quarterly Safety Signal Report

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An FDA safety signal report for the second quarter shows 14 products for which the agency is investigating potential signals of se...

FDA Sends MedImmune a 2nd 'Rejection' Letter on Motavizumab

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FDA sends MedImmune a second complete response letter on motavizumab, this one asking for an additional clinical trial to support ...

Forest and Gedeon Richter See Mixed Results for Antipsychotic

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Forest Laboratories and Gedeon Richter report mixed results from an exploratory Phase 2 trial involving the investigational antips...

FDA Extends Review of Eisai Breast Cancer NDA

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FDA extends by three months its review of an Eisai NDA for eribulin mesylate, indicated for treating locally advanced or metastati...

3 Former Spectranetics Execs Indicted

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A federal indictment accuses three former Spectranetics executives and a fourth person of multiple counts involved in illegally im...

Obama Change Agenda Comes to Nought

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FDA Webview editor Jim Dickinson reviews the Obama change agenda broadly and finds, from FDA to Afghanistan, that it has delivered...

New Cancer Drug Cocktail Rules Coming

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CDER oncology drugs director Richard Pazdur says the agency is working on new research guidelines to facilitate development of can...

FDA 'Orphan' Designation for Pompe Drug by BioMarin

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FDA grants BioMarin Pharmaceutical Inc. an orphan drug designation for BMN-701, an investigational drug under development for trea...

News Briefs

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FDA Review posts news briefs for the week of 8/23-27.

Public Meeting on New Science at CDRH

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Federal Register Notice: FDA plans a public meeting 2/9/10 on incorporating new science into regulatory decisionmaking within CDRH...