Medical Letter on the CDC & FDA
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Drug Development
Regulatory summit panel addresses U.S. FDA process with combination products
February 20th, 2005
When a company has an idea for a new drug, biologic or groundbreaking medical device, it must first put its product through a long and arduous regulatory path before it can reach the public. When 2 different types of medical products are combined into a single "combination product," such as a drug-eluting heart stent, the journey increases exponentially. Combination products are a growing, and relatively recent, phenomenon, which is why the Regulatory Affairs Professionals Society (RAPS) hosted a summit where regulatory affairs (RA) professionals drafted recommendations to address the challenges of this often vexing area of medical product regulation. ...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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