Margaret Hamburg

/Tag:Margaret Hamburg
30 11, 2010

FDA’s Only Getting Tougher

By | 2017-11-06T04:10:49+00:00 November 30th, 2010|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, Form FDA 483, Medical Devices|

It’s been quite a year or two at the FDA since Commissioner Hamburg took over.  Of particular interest to me is their increasingly tough stance on inspections and marketing issues.  Here are some highlights: The FDA wants to prosecute pharma and device execs should their firms engage in off-label marketing.  With what is known as the Park Doctrine, execs could [...]