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FDA Warning Letter Explorer
FDA warning letter · Drugs

"David M. Lubeck, M.D./Arbor Centers for EyeCare

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 submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with investigational new drugs that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].

Citations in the original letter

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

  • 21 CFR 3.2(m)
  • 21 CFR 312.2
  • 21 CFR 312.2(a)
  • 21 CFR 312
  • 21 CFR 312.20(a)
  • 21 CFR 312.20
  • 21 CFR 312.40(b)
  • 21 CFR 312.40