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European Union: authorization of drugs already approved in the United States
by
Papademetriou, Theresa
2015
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Guidance for industry
2004
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Guidance for industry
2001
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Guidance for industry
1998
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Guidance for industry
2004
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Guidance for industry
2001
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Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances
1987
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Guidance for industry
2001
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Clinical trials
by
Brody, Tom
2016
Second edition
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Guidance for FDA reviews and sponsors :
2008
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