Data used to approve some drugs are in doubt after software issue
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
Final FDA guidance distinguishes device recalls from market withdrawals
Guidance outlining requirements for differentiating medical device recalls from market withdrawals has been finalized by the FDA. Apparently taking industry feedback into account, the final guidance revises how the terms "correction" and "removal" are defined. Manufacturers also will no longer be required to report device corrections or removals to the FDA but rather must keep records of them for two years. Regulatory Focus
CDC develops faster laboratory test for detecting enterovirus
The CDC has designed a quick test for identifying enterovirus D68, a rare respiratory virus which has sickened hundreds of children across the country. The test would deliver results in just a few days compared with several weeks for other tests. Increases in confirmed cases of the disease following the introduction of the test "will not reflect changes in real time or mean that the situation is getting worse," according to the agency. The Hill
DIA's educational portfolio offers numerous training and networking opportunities for beginner statisticians, expert statisticians and those considering a career in statistics:
- Adaptive Design in Clinical Trials: When and How to Apply, Oct. 21-22 in Philadelphia, Pa.
- Advanced Signal Detection: Tools, Triage, Evaluation & Escalation, Nov. 3-4 in Washington, D.C.
- Joint DIA/AEMPS Statistics Workshop, Nov. 10-11, Barcelona, Spain
- Basics of Clinical Data Management from Start to End, Dec. 3, Washington, D.C.
- 3rd DIA Statistics Workshop for All Clinical Research Professionals in Japan, Dec. 9-10 in Tokyo
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