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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
France’s Agence nationale de sécurité du medicament et des produits de santé is looking for external experts to help assess the benefits and risks of health products, including medical devices. Read More
The UK’s healthcare costs regulator has decided not to back three new blood tests that are intended to speed the identification of bloodstream bacteria and fungi for routine use in the National Health System. Read More
President Barack Obama signed a measure last week to fund the federal government at fiscal year 2015 levels through Dec. 11, averting a government shutdown. Read More