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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 better drug quality with restructuring

DIA Global SmartBrief | Oct 21, 2014

Novartis drug prolongs progression-free survival in multiple myeloma trial

DIA Global SmartBrief | Oct 21, 2014

Final FDA guidance distinguishes device recalls from market withdrawals

DIA Global SmartBrief | Oct 16, 2014

Adoption of biosimilars could cut overall drug costs

DIA Global SmartBrief | Oct 16, 2014

Australia to rely on European notified bodies for most conformity assessments

DIA Global SmartBrief | Oct 21, 2014

Report: Biotech, pharma and medtech see strong M&A activity

DIA Global SmartBrief | Oct 21, 2014

New bone marrow cancer drug trial to be launched in 2015

DIA Global SmartBrief | Oct 16, 2014

Statistics count

DIA Global SmartBrief | Oct 16, 2014

Ranbaxy settles Texas Medicaid drug-pricing suit for nearly $40M

DIA Global SmartBrief | Oct 21, 2014


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DIA Global SmartBrief | Oct 14, 2014

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