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Synthes Bone Putty Recall is Class 1

[ Price : $8.95]

FDA says a Synthes bone putty recall due to the potential for the putty to ignite during surgery is Class 1.

FDA Releases Modifications to Device Standards

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Federal Register Notice: FDA releases its latest modifications to the list of recognized standards to aid device manufacturers who...

Workshop on Absorbable Medical Devices

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Federal Register Notice: FDA plans a public workshop 11/28 on absorbable medical devices and lessons learned from correlations of ...

FDA Grants Petition to Relax Contrast Agent Warning

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FDA relaxes warning language contained in the approved labeling for GE Healthcares Optison and Lantheus Medical Imagings Definity ...

FDA OKs NSAID Paste for Horses

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FDA approves Bioniche Life Sciences Butequine Paste (phenylbutazone paste), indicated for relieving inflammatory conditions associ...

FDA Clears UTHealth PET Imaging Software

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FDA clears a University of Texas Health Science Center 510(k) for the cfrQuant Coronary Flow Reserve quantification software.

FDA OKs Low Doses for Suboxone

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FDA approves a 4 mg and 12 mg dose for Benckiser Pharmaceuticals Suboxone (buprenorphine and naloxone) sublingual film, indicated ...

Hospiras Dextran 70 Withdrawn

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Federal Register Notice: FDA withdraws approval of a Hospira Inc. NDA for Dextran 70 because it is no longer marketed.

Genzyme Withdrawing Campath in Advance of Lemtrada Approval

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Genzyme withdraws Campath (alemtuzumab) for treating B-cell chronic lymphocytic leukemia in anticipation of obtaining FDA approval...

FDA Approves InSightec IND for Parkinsons System Trial

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FDA approves an InSightec IND for a Phase 1 clinical trial evaluating its ExAblate Neuro system for treating patients with tremor-...