Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Clinical Director Pattanam Srinivasan, of the Advanced Interventional Pain Center, received an FDA warning for serving simultaneously as a study sponsor, clinical investigator and the head of the AIPC institutional review board. Read More
A group of FDA task forces Tuesday recommended that the agency expand the amount of information it releases on inspections and enforcement, allowing the public to view a more detailed record of a company’s compliance history. Read More
Overall reports of adverse events declined over the past three years from 21,729 in 2011 to 14,819 in 2013, according to data published by the UK’s Medicines and Healthcare products Regulatory Agency. Read More