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FDA Warning Letter Explorer
FDA warning letter · Drugs

Daniel Fred Goodman, M.D./Goodman Eye Center

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 clinical investigations with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].

Passage 2

You failed to obtain informed consent and assent of children in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60, 21 CFR 50.20, 21 CFR 50.27, and 21 CFR 50.55].

Passage 3

You failed to adhere to these requirements. Specifically:

Citations in the original letter

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

  • 21 CFR 312
  • 21 CFR 312.2(a)
  • 21 CFR 312.2
  • 21 CFR 312.20(a)
  • 21 CFR 312.20
  • 21 CFR 312.40
  • 21 CFR 312.60
  • 21 CFR 50
  • 21 CFR 50.20
  • 21 CFR 50.27
  • 21 CFR 50.55
  • 21 CFR 50.23
  • 21 CFR 50.24
  • 21 CFR 50.55(a)
  • 21 CFR 50.55(g)
  • 21 CFR 56.109(c)