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Long Beach, Calif.-based Hartley Medical is voluntarily recalling three lots of its Prolotherapy with Phenol injectable because of nonsterility concerns, as drug compounding pharmacies continue to struggle to get their sterile processing systems under control. Read More
Teva is voluntarily recalling 19,504 bottles of amphetamine tablets that could contain impurities, the latest in a series of recalls by the company this year. Read More
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
Vaccines makers should submit individual case safety reports and attachments to the Vaccine Adverse Event Reporting System using either the direct database-to-database method or the eSubmitter tool method, the FDA says. Read More
Teva is voluntarily recalling 19,504 bottles of amphetamine tablets that could contain impurities, the latest in a series of recalls by the company this year. Read More
Eli Lilly Thursday scored its second court victory in less than a week and third overall in lawsuits against its blockbuster antidepressant Cymbalta. Read More
The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by giving drugmakers targeted advice on postmarket study design. Read More
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
Reports of adverse drug reactions in China rose by less than 1 percent last year, compared with 2013, with injectables showing the biggest increase, data released by the China Food and Drug Administration shows. Read More