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Biosimilarity The FDA Perspective

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Name:Biosimilarity The FDA Perspective
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The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy.
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Category:Books
Language:English  English
Total Size:18.06 MB
Info Hash:614EF2CC562F6F49B5FCB64FB5E423ACD15BE1BD
Added By:bookflare Verified UploaderBook Worm
Date Added:2018-11-03 17:26:08
Torrent Status:Torrent Verified


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