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FDA Warning Letter Explorer
FDA warning letter · Drugs

Jeffrey W. Taub, M.D./Children's Hospital of Michigan

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].

Passage 2

You failed to ensure that an IRB that complies with the requirements set forth in 21 CFR part 56 was responsible for the initial and continuing review and approval of the proposed clinical study [21 CFR 312.66].

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 312.60
  • 21 CFR 312.66
  • 21 CFR 312
  • 21 CFR 56