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FDA Warning Letter Explorer
FDA warning letter · Drugs

Lauren R. Klein, MD, M.S.

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 to submit INDs for the conduct of clinical investigations with investigational new drugs subject to 21 CFR 312.2(a) [21 CFR 312.20 and 312.40(a)].

Citations in the original letter

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

  • 21 CFR 312.2(b)(1)
  • 21 CFR 312.2(b)(1)(iii)
  • 21 CFR 312.20
  • 21 CFR 312
  • 21 CFR 312.2(a)
  • 21 CFR 312.3(b)
  • 21 CFR 312.2
  • 21 CFR 312.2(b)
  • 21 CFR 312.7
  • 21 CFR 312.2(d)
  • 21 CFR 50
  • 21 CFR 56