Ferran.Torres@uab.es 97 Fundamental requirement on the phase III documentation Adequate and well-controlled data of good quality Adequate and well-controlled data of good quality A sufficient number of patients, A sufficient number of patients, with a sufficient variety and disease conditions, with a sufficient variety and disease conditions, collected by a sufficent number of investigators, collected by a sufficent number of investigators, demonstrating a positive risk/benefit in the intended population at the intended dose and manner of use.
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