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With an eye toward information exchange and protecting public health, the UK’s Medicines and Healthcare products Regulatory Agency signed an agreement with India’s Central Drugs Standard Control Organization to increase collaboration on medical devices. Read More
Speaking at AdvaMed 2015, FDA Associate Director for International Affairs Kim Trautman renewed her call for participants in the International Medical Device Regulator Forum’s single audit pilot program, saying devicemakers have proven reluctant to join. Read More
While many stakeholders are excited about the 21st Century Cures Act recently passed by the House, industry should be mindful that the Senate version could be quite different. Read More
Peruvian health officials have amended regulations related to medical devices in a move that could prove beneficial for foreign and domestic manufacturers. Read More
The Federal Trade Commission has agreed to the sale of Tornier’s U.S. rights and assets related to its total ankle and total silastic toe joint replacements to Integra Lifesciences. The move came ahead of a vote by Wright Medical Group and Tornier to combine. Read More
When communicating with FDA staff, it is vital that sponsors respond to agency questions during the timeframe requested, or they risk getting a hold letter with additional requests. Read More