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Guidance on Co-Developing Two Combo Drugs

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Federal Register Notice: FDA releases a draft guidance on the co-development of two or more unmarketed investigational drugs for u...

New Offices Added to Tobacco Center

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Federal Register Notice: FDA adds two new offices to its Center for Tobacco Products.

FDA, Pfizer Faulted on Chantix Trials

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The investigative journalism Web site Fairwarning criticizes FDA and Pfizer for not initially testing Chantix on patients with men...

FDA Accepts Pain Drug for Review

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FDA accepts for review a Pacira Pharmaceuticals NDA for Exparel (bupivacaine), a long-acting drug for postsurgical pain management...

Vivus Responds to FDA Qnexa Letter

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Vivus says it has responded to points raised in an FDA complete response letter on its obesity drug Onexa.

BioCheck Marketing Products for Unapproved Use: FDA

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FDAs San Francisco District Office warns BioCheck it is selling in vitro reagents for unapproved uses.

Advocacy Group Says FDA Backs its Antimicrobial Use Warning

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The Union of Concerned Scientists says an unannounced FDA report on livestock antimicrobial use supports its 2001 contention that ...

Life Sciences Waiting on Social Media Rules

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Deloitte Research says some life-science hesitation over using social networks may involve a misperception of how best they can be...

FDA Gives Extension on Chronic Fatigue NDA Resubmission

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FDA grants a 12-month extension to Hemispherx Biopharma for the company to modify its NDA in response to a 11/25/09 complete respo...

FDA Approves New Dosing on HIV Combo Drug

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FDA approves a Tibotec Therapeutics supplemental NDA that revises the dosing recommendation to include once-daily Prezista (daruna...