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Biologics makers developing drugs based on bacteria and viruses should conduct preclinical and clinical studies to determine if infection could be unintentionally transmitted from treated patients to other individuals, the U.S. Food and Drug Administration says. Read More
IPEC-Americas is urging excipient makers to follow its voluntary guideline on stability testing in the wake of recent requests by foreign regulators for stability data. Read More
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance issued Aug. 30. Read More
The U.S. Food and Drug Administration has added Chagas disease and neurocysticercosis to the list of treatments for tropical diseases eligible for priority review vouchers, bringing the number to 19. Read More
EU biopharma groups have lodged a complaint with the European Commission opposing a French law that promotes off-label use of medicines, saying it puts cost ahead of patient safety. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the U.S. Food and Drug Administration, saying draft guidance lacks clear criteria and examples. Read More
Industry groups questioned whether the U.S. Food and Drug Administration has the legal authority to enforce its quality metrics guidance during an Aug. 24 public meeting on the draft document. Read More
The European Medicines Agency’s medical literature monitoring service kicked into full operation Sept. 1, allowing drugmakers to easily search for information on adverse reactions associated with their products. Read More
Lapses in quality management systems and adverse event reporting topped the list of major deviations found during EU postmarking inspections last year, with 18 sites cited for QMS issues and 13 for AE reporting. Read More
The European Medicines Agency is planning to develop an EU portal and database as a single entry point for clinical trial data submissions by May 2016. Read More