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FDAnews Drug Daily Bulletin
Nov. 27, 2012 | Vol. 9 No. 231
API Repackager Linked to Rogue Compounder Gets 483 for Procedural Shortfalls
Although it is up to sponsors and investigators whether to file an IND application, institutional review boards (IRB) still need to review those decisions, according to FDA draft guidance. In cases where the sponsor and investigator have decided not to file, the IRB should request documentation to substantiate the decision, such as a letter from the sponsor or the FDA.
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