Maggie Jeffries, M.D. / Avanti Anesthesiology, LLC — FDA Warning Letter Findings

The investigation does not involve a route of administration, dosage level, use in a patient population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product.

The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use, and there is no intent to use the investigation to support any other significant change in the labeling of the drug.

In the case of a lawfully marketed prescription drug, the investigation is not intended to support a significant change in the advertising for the drug.

The investigation is conducted in compliance with the requirements of 21 CFR 312.7. The clinical investigation of the investigational drugs (diazepam, tramadol, ondansetron, and MKO Melt®) conducted under Protocol ANES001 did not meet the criteria listed at 21 CFR 312.2(b)(1). Specifically, the investigation did not satisfy the third and fourth exemption criteria above. With respect to the third criterion above, the clinical investigation conducted under Protocol ANES001…

The clinical investigation conducted under Protocol ANES001 does not meet the exemption criteria in 21 CFR 312.2(b)(1) and is subject to the IND requirements under 21 CFR 312 . As noted above, FDA regulations require a sponsor to submit an IND before conducting a clinical investigation of a drug in human subjects, unless the clinical investigation qualifies for an IND exemption under 21 CFR 312.2(b). Under 21 CFR 312.2(b)(1), the clinical investigation of a lawfully marketed drug product in the United States is exempt from the IND regulations for a clinical investigation if all of the following exemption criteria are met…