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Standards of clinical investigations in the USA



Standards of clinical investigations in the USA



Methods and Findings in Experimental and Clinical Pharmacology 15(4): 207-215



The drug approval process in the USA is under constant surveillance, monitoring and evaluation. Several significant changes were made during the past few years and many others are under consideration. The FDA has undergone organizational changes, which together with the IND Rewrite and NDA Rewrite resulted in a shift of emphasis in clinical studies.

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Accession: 047430183

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PMID: 8361257


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