GMP: FDA - New draft guidances for Biosimilars
08.03.2012
On 9 February the US Food and Drug Administration published three draft guidance documents on the development of biosimilar products. The intention of these documents is to meet the demands of the requirements of Patient Protection and Affordable Care Act.
The source of the news: http://www.gmp-compliance.org/eca_news_2978_7418,7280.html
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