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Forest Labs and Almirall Plan NDA for COPD Bronchodilator

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Forest Laboratories and Almirall say they are preparing to submit an NDA by mid-2011 on their investigative bronchodilator, inhale...

Pfizer Recalls More 'Musty' Lipitor

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Pfizer recalls two lots (38,000 bottles) of Lipitor 40 mg tablets (atorvastatin calcium) based on reports of an uncharacteristic (...

Cipher Pharma Completes Enrollment in Acne Drug Trial

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Cipher Pharmaceuticals completes enrollment in a Phase 3 safety trial of CIP-Isotretinoin, indicated to treat severe, nodular acne...

Panel to Discuss Pediatric Oncology Products

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 11/30 to discuss pediatric development plans for four prod...

FDA Approves Forest's New Antibiotic

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FDA approves a Forest Labs NDA for Teflaro (ceftaroline fosamil), an injectable cephalosporin antibiotic for treating adults with ...

EpiCept Agrees to FDA-requested Trial on Ceplene

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EpiCept plans to submit a Special Protocol Assessment request for the study, and a request for fast track status.

On Transparency, Its Vote the Rascals Out!

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FDA Webview editors review the multiple failures of transparency efforts at FDA and predict they will contribute to the defeat of ...

Comments Extended on Salmonella in Animal Feed Policy Guide

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Federal Register Notice: FDA extends the comment period on a draft compliance policy guide on enforcement against animal feed or i...

FDA Approves Latuda for Schizophrenia

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FDA approves a Sunovion Pharmaceuticals NDA for Latuda (lurasidone HCl) tablets for treating adults with schizophrenia.

Karen Midthun Tagged as New CBER Director

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FDA selects CBER acting director Karen Midthun as the new Center director.