Search Results for kidney

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European Regulatory Roundup: MHRA Rolls Out Online Portal to Streamline Medical Device Regulatory Services (18 January 2018) By Nick Paul Taylor - Published 18 January 2018

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs

Tags: kidney, MHRA portal

FDA to Put $2.5M Behind Kidney Initiative Meant to Optimize Drug Development By Alexander Gaffney, RAC - Published 10 June 2014

US regulators say they're planning to award at least $500,000, and as much as $2.5 million, to a set of initiatives meant to improve the regulator's understanding of the effects of pharmaceutical products on the kidney.

Categories: News, US, CDER, Drugs

Tags: KHI, ASN, Kidney, Kidney Health Initiative, Grant, Funding, American Society of Nephrology

Dosing Recommendations in Patients with Kidney Damage Focus of Revised EMA Guideline By Alexander Gaffney, RAC - Published 03 March 2014

Categories: EMA

Tags: Liver, Kidney, EU

FDA Opens Innovation Pathway to First Round of Devices By Alexander Gaffney - Published 10 April 2012

Categories: CDRH

Tags: End Stage Renal Disease, Kidney, ESRD, Shuren, Innovation Pathway, Latest News, medical device

Device Innovation Pathway Tackles End-stage Kidney Disease By Louise Zornoza, RegLink - Published 10 April 2012

Categories: Regulatory Update, FDA

Tags: Kidney, ESRD, Innovation Pathway, medical device