Tag Archive: EU

Nov 19 2012

Health Canada Orphan Drug Policy – A Long Overdue Need

Canada is one of the only first world countries without an orphan drug policy. The United States, European Union, Australia, Singapore, and Japan recognized a long time ago the importance of having established policies around the development of orphan drugs. In a 1996 report from Health Canada’s Drugs Directorate that analyzed the need for an …

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Mar 09 2012

After all the talk, where are we with biosimilars?

Biosimilars

In this highly charged political climate, no news broadcast is complete without some mention of healthcare.  Frequently the focus is on healthcare costs, which is one reason that the government charged the FDA in 2010 with creating the 351(k) approval process for biosimilars (generic versions of biologically manufactured products).  Well-known marketed biologics in the U.S. …

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Jul 14 2011

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

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Feb 22 2011

A Brief Update on FDA’s Re-evaluation of the 510(k) Process

Change is in the air.  No, I’m not referring to the recent thaw here in Minnesota, but rather to the looming changes in the regulations governing medical devices in the U.S. First, a brief primer on the medical device approval process in the U.S.  Currently, all novel medical devices must be approved through a “de …

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Oct 18 2010

RAPS Preconference Workshop – EU Regulatory Affairs Essentials

Image via Wikipedia The 2010 RAPS Annual Conference and Exhibition will be from Sunday, 24 October to Wednesday, 27 October at the McEnery Convention Center in San Jose, CA.  While  the “main event” kicks off on Monday, 25 October at 8:30 AM, you should make sure to be in town on Sunday, 24 October to …

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