Tag Archives: Medical Devices
By Reflector | Published: September 18, 2013
EuropeNew Device and Diagnostics Legislation Will Shake Up Drug Industry The shockwaves from the current European Union debates in Brussels on medical devices are are likely to echo through the medicines business over the next few years. This month, the European parliament’s health committee will reach its view on the two major proposals launched last year by EU [...]
By Guest Blogger | Published: September 18, 2013
In August of 2013, the FDA released a report that analyzed clinical trial subject demographic subgroups for FDA approved medical products, which included factors such as race, age and gender. After reviewing the report in detail, I started thinking about the importance of incorporating diversity into clinical trials. What Did the Report Find???This report analyzed data [...]
By Guest Blogger | Published: April 4, 2013
by William Kitchens On March 21, 2013, the United States Senate approved an amendment by a vote of 79 to 20 to repeal the 2.3 percent medical device excise tax. The tax, which went into effect this past January, was included as part of the Patient Protection and Affordable Care Act.
By Ben Comer | Published: April 1, 2013
Over the next few years, med tech company Becton Dickinson will launch up to 30 generic, pre-filled syringes in an attempt to lower medication errors and raise company revenues, according to BD Rx president Mark Sebree. One man’s goof is another man’s growth, potentially.
By Guest Blogger | Published: September 5, 2012
by Elizabeth Hollis The FDA and the Advanced Medical Technology Association (AdvaMed) gave cardiovascular device manufacturers plenty to think about over the holiday weekend with information presented at an Aug. 28 workshop. The two bodies came together to explain requirements for 30-day notices and annual change reports for Pre-Market Approvals (PMAs), an important gateway to [...]