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The FDA emphasized flexibility in a Monday final guidance that attempts to harmonize U.S. and International Conference on Harmonisation drug photosafety testing requirements. Read More
In a 46-page draft guidance released Monday, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
Antares Pharma received an FDA complete response letter for labeling issues and minor deficiencies in its ANDA for sumatriptan injection USP, the company said in a Monday SEC filing. Read More
Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
Authorities in the UK are urging physicians not to prescribe valproate drugs to pregnant women and to inform women who truly need the drug of potential risks to their unborn children. Read More
Drugmakers and industry groups are urging regulators in Australia to abandon proposed new requirements that call for larger type on drug labels and that labels be made and applied so that they cannot be damaged by opening a product. Read More
An FDA advisory committee may have given its unanimous approval for a biosimilar application this month, but industry and patient groups contend the regulatory pathway still has many potholes and unanswered questions. Read More