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Sterigenics Sterilization Facility Temporarily Closed

[ Price : $8.95]

FDA says Sterigenics contract sterilization facility in Atlanta, GA is temporarily closed while it undergoes construction to reduc...

Qfix Encompass 15-Channel Head Coil Cleared

[ Price : $8.95]

FDA clears a Qfix 510(k) for the Encompass 15-Channel Head Coil, a diagnostic imaging device for use with the Encompass MR SRS Imm...

FDA Posts 9 OMB-approved Info Collections

[ Price : $8.95]

Federal Register notice: FDA posts a list of ninee information collections that have been approved by OMB.

Four 510(k) Guidances Out

[ Price : $8.95]

FDA publishes four guidances giving its thinking on several aspects of the 510(k) submission process.

FDA Clears GE Critical Care Suite

[ Price : $8.95]

FDA clears the GE Healthcare Critical Care Suite that uses artificial intelligence algorithms embedded on a mobile X-ray device.

Science Board to Discuss CBER Research

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Federal Register notice: FDA announces a 10/7 Science Board meeting to hear CBERs response on its research program.

Hearing on Fecal Microbiota for Transplantation

[ Price : $8.95]

Federal Register notice: FDA announces an 11/4 public hearing to obtain input on the use of fecal microbiota for transplantation t...

Treatment Effect Influences FDA Approval Decisions: Study

[ Price : $8.95]

Researchers say they could not find a clear threshold of magnitude of treatment effect that would lead FDA to not request randomiz...

Regulatory Review Period for Edwards Aortic Bioprosthesis

[ Price : $8.95]

Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Edwards Lifesciences Perica...

EMD Serono Gains Breakthrough for Lung Cancer Drug

[ Price : $8.95]

FDA grants EMD Serono a breakthrough therapy designation for its investigational targeted therapy tepotinib in certain patients wi...