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Akebia Resubmitting Kidney Disease NDA

[ Price : $8.95]

Akebia Therapeutics completes an End of Dispute Type A meeting with FDA that discussed the companys upcoming NDA resubmission for ...

Medtronic Recalls Faulty Defibrillators

[ Price : $8.95]

Medtronic recalls its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with glassed fe...

Olympus Recalls Bronchoscopes Over Laser Compatibility

[ Price : $8.95]

Olympus recalls about 1,500 OES BronchoFiberscope BF Type devices after receiving complaints of endobronchial combustion during th...

Suggestions for Pediatric Drug Guidance

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Four drug stakeholders suggest changes to a draft FDA guidance on scientific considerations in pediatric drug development.

GAO Regenerative Medicine Policy Options

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A Government Accountability Office report on the challenges of regenerative medicine therapies and technologies offers 11 policy o...

Elevar Therapeutics NDA for Liver Cancer

[ Price : $8.95]

FDA accepts for review an Elevar Therapeutics NDA for rivoceranib, an oral tyrosine kinase inhibitor in combination with camrelizu...

Catalent Indiana Facility Cited in Form-483

[ Price : $8.95]

FDA gives Catalent a four-page Form FDA-483 after inspecting the firms Bloomington, IN manufacturing facility 5/4-12.

Quidel Cardio Recalls Cardiac Panel Test

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Quidel Cardiovascular recalls the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected tropon...

Guide Updated on Device Development Tools

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FDA updates its final guidance entitled Qualification of Medical Device Development Tools (MDDTs).

Ex-FDA Chief Counsel Joins Berkley Research

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Former FDA chief counsel Dan Troy joins Berkeley Research Group in the firms Washington, DC office as a managing director in its ...