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The International Conference on Harmonisation is recommending that drugmakers limit their use of the solvent methylisobutylketone in drug products after two studies showed toxicity in rats and mice. Read More
The second phase of ISPE’s quality metrics pilot program — which kicked off this month — will continue as planned, despite differences in its metrics and the quality data the FDA plans to collect, says the co-chair of ISPE’s quality metrics team. Read More
Drugmakers in Australia are urging the Therapeutic Goods Administration to raise the number of patients required for classifying an orphan disease, saying it would bring the threshold in line with the EU, Canada and Switzerland. Read More
The European Commission is suspending sales and distribution of 700 formulations of more than four dozen generic drugs after determining that the bioequivalence testing on which their approvals were based included manipulated echocardiogram data. Read More
Drugmakers in the EU have less than eight months to conduct risk assessments of all the excipients they use, under good manufacturing practices guidelines imposed by the European Commission. Read More
Particulates have forced Teva to voluntarily recall lots of its anticancer therapy Adrucil for the second time since May, after silicone rubber pieces from a filler diaphragm and fluorouracil crystals were found in six lots of the product, totaling over 30,000 vials. Read More
Indian active pharmaceutical ingredient maker Mahendra Chemicals was hit with an FDA warning letter for cGMP deviations including data integrity issues — the latest in a crackdown on foreign API makers. Read More