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CDER Seeks Translational Sciences Deputy Director

[ Price : $8.95]

CDER conducts a nationwide search for the permanent position of Office of Translational Sciences deputy director for science as cu...

FDA Approves Medtronics Artificial Pancreas

[ Price : $8.95]

FDA approves Medtronics MiniMed 670G hybrid closed looped system, the first agency-approved device or artificial pancreas that is ...

FDA OKs Abbotts FreeStyle Continuous Glucose Monitor

[ Price : $8.95]

FDA approves an Abbott PMA for the FreeStyle Libre Pro system, a continuous glucose monitoring system for healthcare professionals...

Adaptive Design Guidance Explained

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CDRH and CBER officials discuss a final guidance on adaptive clinical trial designs in an agency webinar.

DePuy Synthes Recalls Exploding Surgical Tool Batteries

[ Price : $8.95]

DePuy Synthes recalls its Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor, which are used in the companys...

Infuse Cases Dismissed

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An Ohio federal court dismisses all elements in a consolidated claim by five plaintiffs against Medtronic alleging various forms o...

FDA Clears Medtronic StealthStation Cranial Software

[ Price : $8.95]

FDA clears a Medtronic 510(k) for the StealthStation cranial software as an aid for deep brain stimulation lead placement.

FDA Clears Quidel Influenza Assay

[ Price : $8.95]

FDA clears a Quidel 510(k) to market its Solana Influenza A+B assay for detecting nucleic acids isolated from nasal and nasopharyn...

FDA Clinical Hold on CEl-SCI Multikine Phase 3 Study

[ Price : $8.95]

FDA places a clinical hold on a CEL-SCI Corp. Multikine (leukocyte interleukin injection) Phase 3 clinical trial in advanced prima...

FDA Again Rejects Pain Therapeutics Remoxy NDA

[ Price : $8.95]

FDA sends Pain Therapeutics a third complete response letter on its NDA resubmission for Remoxy ER (oxycodone capsules), asking fo...