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FDA Warning Letter Explorer
FDA warning letter · Drugs

New York State Psychiatric Institute IRB

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

Failure of the IRB to prepare, maintain, and follow required written procedures raises concerns about the adequacy of the IRB's review processes for ensuring the protection of the rights and welfare of human research subjects.

Citations in the original letter

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

  • 21 CFR 56.108(b)
  • 21 CFR 56.108(c)
  • 21 CFR 56.115
  • 21 CFR 56.113