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FDA Warning Letter Explorer
FDA warning letter · Drugs

Angela D. Ritter, 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 adhere to the requirements for all expanded access uses [21 CFR 312.305(c)].

Passage 2

You failed to adhere to these requirements. Specifically, FDA authorized the individual patient expanded access for emergency use (subject’s initials: **(b)(6)**) under IND #**(b)(4)** on May 14, 2020. However, you failed to comply with all the requirements for the expanded access use.

Citations in the original letter

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

  • 21 CFR 312
  • 21 CFR 312.305(c)
  • 21 CFR 312.305(c)(5)
  • 21 CFR 312.305(c)(3)
  • 21 CFR 312.50
  • 21 CFR 312.305(c)(4)
  • 21 CFR 312.66
  • 21 CFR 312.33
  • 21 CFR 312.310
  • 21 CFR 56
  • 21 CFR 56.104(c)