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FDA Warning Letter Explorer
FDA warning letter · Drugs

Maria W. Greenwald, M.D.

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 ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].

Passage 2

You failed to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation [21 CFR 312.62(b)].

Citations in the original letter

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

  • 21 CFR 312.60
  • 21 CFR 312.62(b)
  • 21 CFR 312