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Sen. Franken Introduces Device Reform Bill

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Sen. Al Franken (D-MN) introduces the Patient Access to Medical Innovation Act to get innovative medical devices to market more qu...

FDA Clears Calix PC Spinal Implant System

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FDA clears an X-Spine 510(k) for the Calix PC Spinal Implant System, an intervertebral body fusion system.

Distribution of Pennsaid Samples Stopped

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FDA asks Mallinckrodt to stop distributing 15 mL sample bottles of Pennsaid due to reports of improper administration by patients.

Bill Would Limit Commissioners Terms, Boost Innovation

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Sen. Kay Hagan proposes legislation to set a fixed six-year term for the FDA commissioner and create new drug approval pathways.

LASIK Facility Warned About MDR Violations

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FDA warns Laser Eye Care of California about medical device reporting violations at its laser surgery facility.

Consumers Union Wants Medical Device Safety Reforms

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Consumers Union calls on Congress to strengthen, rather than weaken, medical device safety requirements.

Geron Focusing on Cancer, Ending Spinal Cord Trial

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Geron says it is ending enrollment in its stem cell spinal cord injury trial to concentrate on two oncology drugs.

FDA Says Intellipharmaceutics Canadian Facility is Acceptable

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FDA has given acceptable status to an Intellipharmaceutics drug manufacturing facility.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Leslie Diaz, Laser Eye Care of CA, Medical Compression Systems, Rainbow Ltd dba ...

IMS Recommends FDA Early Warning System for Shortages

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A new report from IMS Institute for Healthcare Informatics recommends that FDA or the healthcare industry establish an early warni...