House holds hearing on FDA’s authority over compounding pharmacies *

USA - April 30 2013
In light of the 2012 fungal meningitis outbreak, regulation of pharmacy drug compounding has received significant attention. On April 16, 2013 the…

Co-authors: Emalee G. Murphy.

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FDA issues guidance on medical device product codes *

USA - April 17 2013
The Food and Drug Administration (FDA) announced on Thursday, April 11, 2013, the availability of a guidance document entitled "Medical Device…

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Despite growing momentum repeal of medical device tax faces significant hurdles *

USA - April 3 2013
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…

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What’s happening with Food Safety Modernization Act rules *

USA - March 7 2013
While the industry waits for the new rules under the Food Safety Modernization Act (FSMA), here's what I see the FDA is doing regarding these new…

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Am I my competitor’s keeper? Alabama’s highest court holds brandname prescription drug manufacturer liable for claims on a generic drug used by the plaintiff *

USA - February 5 2013
The Supreme Court of Alabama recently held that "[u]nder Alabama law, a brand-name drug company may be held liable for fraud or misrepresentation (by…

Co-authors: W. Jerad Rissler.

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