§ 812.42. FDA and IRB approval.
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/us/cfr/t21/s§ 812.42·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation. [46 FR 8957, Jan. 27, 1981]
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§ 812.42
FDA and IRB approval.
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