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FDA Warning Letter Explorer
FDA warning letter · Drugs

"Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases

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 these requirements. Specifically, you enrolled subjects in **(b)(4)** and subsequently in an open-label extension study, Protocol **(b)(4)**; however, each of these subjects had previously been enrolled and was actively participating in another clinical study, Protocol **(b)(4)**, involving another study drug (**(b)(4)**). Examples of this failure include, but are not limited to, the following:

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