BotableBook a call
FDA Warning Letter Explorer
Drugs · Jul 14, 2022

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

3 extracted findings · 2 model-assigned issue types

FDA source excerpt, selected passage

You initiated and conducted a clinical investigation of an investigational drug subject to section 505 of the FD&C Act before submitting and having in effect an

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Registration, listing & premarket21 CFR 312.20(a) 21 CFR 312.20(b) 21 CFR 312.40(a)

The sponsor-investigator initiated and conducted a clinical investigation without having an IND in effect before enrolling and treating subjects.

Supporting FDA text
Source excerpt · automated text-match check

You initiated and conducted a clinical investigation of an investigational drug subject to section 505 of the FD&C Act before submitting and having in effect an

Clinical research & IRB21 CFR 312.60 21 CFR 50.20 21 CFR 50.27 21 CFR 50.55

The investigator failed to obtain legally effective written informed consent from subjects before enrollment.

Supporting FDA text
Source excerpt · automated text-match check

You failed to obtain legally effective written consent from subjects before their enrollment in Protocol (b)(4).

Clinical research & IRB21 CFR 312.60 21 CFR 50.20 21 CFR 50.27 21 CFR 50.55

The investigator failed to obtain IRB-required written assent from minor subjects before enrollment.

Supporting FDA text
Source excerpt · automated text-match check

You failed to obtain written assent of subjects between the ages of 10 and 17 before their enrollment in the study, as required by the IRB.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
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)].
21 CFR 312.2(a) 21 CFR 312.20(a) 21 CFR 312.20 21 CFR 312.2
02
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].
21 CFR 50 21 CFR 312.60 21 CFR 50.20 21 CFR 50.27 21 CFR 50.55 21 CFR 50.23 21 CFR 50.24 21 CFR 56.109(c)
03
You failed to adhere to these requirements. Specifically:

What FDA requested

Model-assisted summary. Consult the letter for complete requests and conditions.

  • Notify FDA in writing of actions taken to prevent similar violations
  • Provide information on how sponsor-investigator will determine when IND is required

Sections and clauses cited

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

21 CFR 5021 CFR 31221 CFR 312.2(a)21 CFR 312.221 CFR 50.2021 CFR 50.2721 CFR 312.20(a)21 CFR 312.2021 CFR 312.4021 CFR 312.6021 CFR 50.5521 CFR 50.2321 CFR 50.2421 CFR 56.109(c)21 CFR 50.55(a)21 CFR 50.55(g)

Explore Botable’s work in Pharmaceuticals.

Keep exploring

More drug letters

Recent records for the same product type. Your previous filters remain available when you return.

Keep exploring

Find related letters →Browse your letters
For regulated teams

Put this kind of reading to
work on your own records.

Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.

Book a call ↗Read the case studies

FDA Warning Letter Alerts

Share this view

Send the same filters, search and view to a colleague.

LinkedIn Email

You choose what to post or send. Sharing a link does not change access to this site.