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NDMA Testing on Ranitidine Better Than First Thought: FDA

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An FDA update on an ongoing investigation about a contaminant known as N-Nitrosodimethylamine found in ranitidine (Zantac) says th...

Xact Robotics Percutaneous Interventional Device Cleared

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FDA clears an Xact Robotics 510(k) for its robotic system and its use during computed tomography guided percutaneous interventiona...

Thoratec Recalls CentriMag Systems

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Thoratec Switzerland recalls its CentriMag Acute Circulatory Support System Motor, which is a component of the CentriMag Extracorp...

Mexitil Not Withdrawn Over Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Boehringer Ingelheims Mexitil (mexiletine hydrochloride) was not withdrawn from sale ...

Stryker Sahara Lateral 3D Spine Implant Cleared

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FDA clears a Stryker 510(k) for its Sahara Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology.

Senators Have More Software Pre-Cert Questions

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Sens. Warren, Murray, and Smith raise 18 additional questions for FDA to answer on its software pre-certification program.

GDUFA 2 User Fee Assessment

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FDA issues a draft guidance on changes affecting its implementation of GDUFA 2 user fees.

Genentech BLA Submitted for Satralizumab

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FDA accepts for review a Genentech BLA for satralizumab for treating adults and adolescents with neuromyelitis optica spectrum dis...

Developing Drugs for Hepatitis D Virus Infection

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FDA publishes a draft guidance to assist sponsors develop drugs to treat hepatitis D virus infection.

Meeting on Health Equity Related to Opioid Crisis

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Federal Register notice: FDA announces an 11/21 public meeting entitled Office of Minority Health and Health Equity Public Meeting...