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Sharing links and information about FDA and other regulatory related topics:

Mass. Sen. hopeful Elizabeth Warren on the device tax, the FDA and a climate for innovation (MassDevice)

FDA wants more patients to learn about and offer feedback on drug/device approvals (MedCityNews)

South Korean medical device approvals up 7% in 2012 (MassDevice)

Adoption of Adaptive Design Trials on the Increase (Aptiv Solutions)

U.S. FDA guidance explains user fees for medical device reviews (MassDevice)

 FDA releases draft Sunshine Law guidelines (MassDevice)

And Then There Were Eight: the 2013 Revision of EU Vigilance Guidelines for Medical Devices (Medtechinsider Blog)

UK MHRA Launches Innovation Office (Medtechinsider Blog)

Hamburg Touts Regulatory Flexibility of Agency, Notes Upcoming Breakthrough Guidance (Regulatory Focus)

Legislative Amendment Could Affect FDA’s Ability to Meet with Industry (Regulatory Focus)

See our Regulatory archives for older stories.