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Data used to approve some drugs are in doubt after software issue

DIA Global SmartBrief | Oct 16, 2014

A European Medicines Agency official said regulators would meet next week to discuss an apparent software glitch involving Thermo Fisher Scientific's Kinetica package for analyzing bioequivalence, which could put the reliability of clinical tests used to obtain approval for some drugs in doubt. Some drugs could have been approved while others may have been denied approval or were never filed because of incorrect data. The possible problem may extend to drugs filed for approval in the U.S., the EU and beyond, though the scale of the problem has not been determined. Reuters (10/13)


FDA seeks patient input on 16 medical conditions

DIA Global SmartBrief | Oct 14, 2014

Chinese pharma company to develop Ebola drug

DIA Global SmartBrief | Oct 14, 2014

NHS proposes re-evaluation of drugs for reimbursement

DIA Global SmartBrief | Oct 14, 2014

Oral pills effective in treatment of Clostridium difficile, study finds

DIA Global SmartBrief | Oct 14, 2014

NICE guidance aims to improve use of medicines

DIA Global SmartBrief | Oct 14, 2014

New molecule could speed up search for Ebola drugs

DIA Global SmartBrief | Oct 14, 2014

Adoption of biosimilars could cut overall drug costs

DIA Global SmartBrief | Oct 16, 2014

Final FDA guidance distinguishes device recalls from market withdrawals

DIA Global SmartBrief | Oct 16, 2014

New bone marrow cancer drug trial to be launched in 2015

DIA Global SmartBrief | Oct 16, 2014


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