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FDA Clears Osseoflex Needle for Spine Fractures

[ Price : $8.95]

FDA clears an Osseon Therapeutics 510(k) for the Osseoflex SN (steerable needle) for treating spinal compression fractures.

FDA Approves Sagent Muscle Relaxant

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FDA approves Sagent Pharmaceuticals' 505(b)(2) NDA for orphenadrine citrate for injection, a skeletal muscle relaxant.

Reclast Labeling Changes on Kidney Failure

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FDA says labeling for Reclast has been updated to reflect the risk of kidney failure.

FDA Gives Advisors Surgical Mesh Reports

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FDA gives advisors surgical mesh adverse event reports to consider during a 9/8-9 meeting.

FDA Safety Alert on Merck's Saphris

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A new FDA drug safety alert warns about serious allergic reactions that have been reported with Merck's antipsychotic Saphris (ase...

FDA Accepts Avanafil NDA for Erectile Dysfunction

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FDA says it will review a Vivus avanafil NDA with a proposed indication for treating erectile dysfunction.

FDA Approves Baxter Expanded Indication for Artiss

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FDA approves an expanded indication for Baxter International's Artiss [fibrin sealant (human)] to include adhering tissue flaps du...

Enforcement Request Petition Denied for Azithromycin

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FDA denies a citizen petition seeking enforcement action against three companies selling generic azithromycin that the petitioners...

Former HHS General Counsel Joins King & Spalding

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Former HHS acting general counsel Preeya M. Noronha joins King & Spalding's FDA and life sciences practice as counsel in Washingto...

Congressman Complains to Obama About FDA

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Rep. Erik Paulsen complains to President Obama about pending 510(k) approval pathway changes being considered by FDA.