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The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by providing drugmakers with targeted advice on postmarket study design. Read More
The FDA zapped three more compounders over sterility issues, with two Tennessee firms receiving Form 483s and a California facility getting hit with a warning letter. Read More
Pfizer has terminated its over-the-counter Lipitor program in the U.S. after a Phase 3 clinical trial showed that patients required a physician’s help to take the cholesterol-lowering drug correctly. 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