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# ‘Objectionable Conditions’ in Goodman Eye Center Trial
- URL: https://www.fdaweb.com/objectionable-conditions-in-goodman-eye-center-trial/
- Published: 2022-07-27T12:00:00.000Z
- Updated: 2026-09-14T17:53:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152384

An 11/29-12/13/21 FDA inspection at the Goodman Eye Center, San Francisco, CA, conducted as part of the agency’s Bioresearch Monitoring Program, found objectionable conditions associated with a clinical trial conducted at the site. A 7/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/daniel-fred-goodman-mdgoodman-eye-center-634247-07142022?ref=fdaweb.com) emphasized these issues:

- failing to submit an IND for the conduct of clinical investigations with an investigational new drug that is subject to regulations; and
- failing to obtain informed consent and assent of children in accordance with regulations.

“We acknowledge the corrective and preventive actions that you state you are implementing and your assurance that verbal consents and assents were obtained,” the letter says. “However, despite your statements, we remain concerned that you did not obtain written consent from subjects and written assent from minor subjects, as required, before enrolling subjects and administering investigational product. We are particularly concerned about the severity of the violations and their potential impact on subjects’ rights, considering that pediatric subjects are a vulnerable population.”

Dr. **Daniel Fred Goodman** was told to respond with a list of specific actions that have been taken to prevent similar violations in the future.