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Tag: drug administration
Covidien Announces U.S. Food and Drug Administration 510(k) Clearance ...
2014-10-10 04:51:58| Industrial Machines - Topix.net
Covidien plc today announced U.S. Food and Drug Administration 510 clearance for the Nellcor Portable SpO2 Patient Monitoring System . The system is the only commercially available portable oximeter that is equipped with home care and sleep study modes and complies with Part of a comprehensive Covidien respiratory function monitoring portfolio, this convenient, handheld patient monitor is simple to use and ideal for fast, accurate, motion-tolerant monitoring of pulse rate and blood oxygenation .
Tags: food
administration
drug
clearance
Vertex Submits Supplemental New Drug Application (sNDA) To U.S. Food And Drug Administration For Use Of KALYDECO (ivacaftor) In People 18 And Older With Cystic Fibrosis Who Have The R117H Mutation
2014-07-02 10:30:30| drugdiscoveryonline Home Page
Vertex Pharmaceuticals Incorporated recently announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of KALYDECO in people with cystic fibrosis (CF) ages 18 and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
U.S. Food and Drug Administration Issues Complete Response Letter for Empagliflozin
2014-03-06 03:01:17| Biotech - Topix.net
The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured.
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issues
food
response
Covidien Announces U.S. Food and Drug Administration 510(k) Clearance ...
2014-02-27 07:00:29| Industrial Machines - Topix.net
Covidien plc , a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced its Puritan Bennett 980 ventilator has received U.S. Food and Drug Administration 510 clearance.
Tags: food
administration
drug
clearance
Administration to Add New Drug Inspectors in China
2013-12-19 01:00:00| ThePigSite - Industry News
CHINA - In an effort to eliminate the weak industry oversight, the US Food and Drug Administration (FDA) has decided to add 10 new drug inspectors to its office in China.
Tags: add
china
administration
drug