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Six drug company stakeholders ask FDA for changes to an agency draft guidance on post-approval changes to drug substances.

Restrictions Sought on Zelnorm sNDA

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Hyman, Phelps & McNamara asks FDA not to approve a Zelnorm sNDA without substantial evidence of safety and efficacy under currentl...

Synaptive Medical Recalls BrightMatter Guide

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Synaptive Medical recalls its BrightMatter Guide with SurfaceTrace Registration due to a software defect that could potentially re...

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...

Discussion Document on Patient Engagement in Device Trials

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FDA releases a discussion document on patient engagement in the medical device clinical trial process as a follow-up to its 10/201...

FDA Plans to Retire Outdated 510(k) Predicates

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FDA says it is examining ways to modernize the medical device 510(k) process by relying more on a review that weighs new technolog...