FDA 483 - Neil S. Sadick, M.D. - October 09, 2024

During an FDA inspection from September 23 to October 9, 2024, of Neil S. Sadick, M.D., a clinical investigator at Sadick Anesthetic Surgery & Dermatology in New York, NY, an observation was made regarding the conduct of Protocol (b)(4) and Protocol (b)(4).

The primary observation was that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, for Protocol (b)(4), Amendment 11, dated May 4, 2023, which required re-consenting patients for protocol amendments altering study design or increasing risk, six out of seven enrolled subjects were not re-consented. This included failure to use the IRB-approved informed consent form (ICF) version dated March 16, 2023, which included common side effects, and the ICF version dated June 15, 2023, which discontinued a specific dosage due to new potential serious safety concerns.

Additionally, for Protocol (b)(4), Version 1, dated July 10, 2024, two out of four enrolled subjects lacked documented medical history to verify inclusion and exclusion criteria. This included history of inadequate response or inadvisability of topical treatments, any medical or psychiatric condition like active suicidal ideation, and active or chronic infection requiring systemic treatment prior to baseline. These subjects were screened on January 2