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Best Practices with FDA for Firms During Drug Development

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FDA plans a draft guidance on best practices for communications between agency reviewers and drug sponsors during product developm...

Wright Medical Unit Approvable Letter for Augment Bone Graft

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Wright Medical Groups BioMimetic subsidiary gets an Approvable Letter from FDA for its PMA on its Augment Bone Graft as an alterna...

Daiichi Stroke Drug No Better than 3 Others: FDA Reviewers

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Medical reviewers tell the FDA Cardiovascular and Renal Drugs Advisory Committee that Daiichi Sankyos Savaysa shows no advantages ...

Fast Track Granted for Araim Pharma Drug

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FDA grants Araim Pharmaceuticals a fast track designation for its lead compound ARA290 for treating sarcoidosis-associated small f...

FDA Promoting Non-clinical CV Toxicity Testing: Throckmorton

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CDER deputy director for regulatory programs Douglas Throckmorton says the agency is helping drug companies find non-clinical test...

Government Seeks Injunction Against Laser Maker

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The Justice Department files a civil complaint for injunctive relief in South Dakota federal court against 2035 Inc. for marketing...

Guidance on Galactomannan Detection in Aspergillosis

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Federal Register Notice: FDA makes available: Draft Guidance on Qualification of Biomarker Galactomannan in Studies of Treatments...

Pfizer Walks Away From Remoxy Development

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Pfizer tells its development partner Pain Therapeutics that it has decided to discontinue its agreement to develop and commerciali...

Baxter Recalls 2 Intravia Container Lots

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Baxter International recalls two lots of Intravia containers in the U.S. and Canada due to complaints about particulate matter fou...

Group Challenges FDA on Animal Data Reliance

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The Center for Responsible Science says FDA should refine its recently released Draft Informed Consent Information Sheet: Guidance...