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Class 1 Recall for Zimmer Spinal Fusion Stimulators

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FDA classifies as Class 1 a Zimmer Biomet recall of its EBI Osteogen Implantable Bone Growth Stimulator, SpF Plus-Mini (60 μA...

FDA OKs Bayer/Loxo Targeted Cancer Drug

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FDA approves Bayer and Loxo Oncologys Vitrakvi (larotrectinib) for treating adult and pediatric cancers in patients who have a spe...

FDA Heading to Sliding Scale of Medical Device Evidence: Lurie

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Former FDA associate commissioner Peter Lurie says FDA may have to lower its medical device approval standards if it wants to be t...

FDA Cuts Minimum Measles Antibody Potency Spec

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FDA says it is lowering the minimum measles antibody potency specification for immune globulin products.

Preventable Deaths Due to FDA: Analysis

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A Goldwater Institute investigative report faults FDA caution in approving new drugs, saying it stifles innovation and leads to un...

FDA Rejects BioElectronics Expanded Use for ActiPatch

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FDA declines a BioElectronics 510(k) submission for its ActiPatch, seeking expanded over-the-counter indications for treating musc...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include The Delano Co. and Mylan Pharmaceuticals.

Drug Post-Approval Change Guidance Comments

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Six drug company stakeholders ask FDA for changes to an agency draft guidance on post-approval changes to drug substances.

QS Issues at Mylan Morgantown Plant

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FDA warns Mylan about CGMP violations at its Morgantown, WV, drug manufacturing facility.

Clinical Hold Placed on Zafgen Diabetes Therapy

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FDA places a clinical hold on a Zafgen clinical trial of ZGN-1061, the companys second-generation, investigational MetAP2 inhibito...