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FDA Warning Letter Explorer
FDA warning letter · Drugs

Sourav K. Mishra, M.D. / All India Institute of Medical Sciences

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 adhere to this requirement. Specifically, all three enrolled subjects were orally administered Aprecap (aprepitant), a moderate inhibitor of CYP3A4, during the study. Examples of these failures include:

Passage 3

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

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
  • 21 CFR 320.31(c)
  • 21 CFR 50
  • 21 CFR 50.20
  • 21 CFR 50.22