Regulatory and Compliance
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Oct 15, 2013
Consultant Chang-Hong Whitney, president, Whitney Consulting, has a simple message for all U.S. and Western medtech companies seeking to commercialize in...
Oct 11, 2013
 By Jim Dickinson Should FDA’s cops be led by veterans with actual experience in the trenches or doesn’t that matter anymore? It’s a...
Oct 09, 2013
      It's no secret that there's a strong bipartisan group that wants the Affordable Care Act (ACA) out of the window, but the Obama...
Oct 08, 2013
By: Jim Dickinson FDA in September appointed former Central Region food and drug director Melinda Plaisier as its new associate commissioner for regulatory...
Oct 07, 2013
Post-operative quality-of-life studies on military personnel who have undergone LASIK eye surgeries have been delayed indefinitely due to personnel “...
Sep 30, 2013
  Given the proliferation of medical devices using wireless technology—and the accompanying risks regarding security, performance, compatibility,...
Sep 27, 2013
Medtronic announced on Friday that the FDA has approved its MiniMed 530G with Enlite sensor, that has the capability of automatically suspending insulin...
Aug 30, 2013
By: Jim Dickinson AdvaMed says that a CDRH draft guidance on using international standard ISO-10993 on biological evaluation of medical devices is inconsistent...
Aug 29, 2013
by: Jim Dickinson Harvard Medical School assistant clinical professor Perry Rosenthal lashed out in August at what he alleges is FDA’s continuing failure...
Aug 29, 2013
                     As director of the regulatory affairs program at The George Washington University,...