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The International Conference on Harmonisation has issued first-ever quantitative guidance on the evaluation and control of mutagenic impurities in medicines to limit potential cancer risk. Read More
The International Conference on Harmonisation has issued first-ever quantitative guidance on the evaluation and control of mutagenic impurities in medicines to limit potential cancer risk. Read More
Sun Pharma is recalling more than 216,000 bottles of felodipine blood pressure tablets and the antidepressant imipramine because the varnish on labels is leaching a chemical into the containers. The news comes on the heels of a July recall of bupropion hydrochloride tablets made at Sun’s Halol, Gujarat, India, plant. Read More
The FDA awarded a three-year contract to the American Society of Health-System Pharmacists to develop and implement standardized concentrations for intravenous and oral liquid medicines as part of the agency’s Safe Use Initiative. Read More
The FDA is evaluating the potential risks of prescribing tramadol for children 17 years and younger because it may cause slowed or difficult breathing. The opioid drug is not approved for use in children, but is being prescribed “off-label.” Read More
FDA has placed a hold on clinical trials of long-term cognitive treatment encenicline after some patients experienced serious gastrointestinal concerns, Forum Pharmaceuticals and its Japanese partner reported. Read More