GMP: FDA publishes Draft Guidance on Classification of Products as Drugs or Devices
13.07.2011
Based on the number of requests from manufacturers addressed to the Agency concerning the classification of their products as a drug or a device, the FDA published a new guidance which should help them classify their products. Even the distinction between combination products and biological products is made in the document too.
The source of the news: http://www.gmp-compliance.org/eca_news_2643_6892,7009.html
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