# Investigational New Drug applications *A federal filing in U.S. drug-research law, and the at-issue entry recording FDA warning letters to two Minnesota county-hospital physicians for studies conducted without it.* The Investigational New Drug (IND) application is catalogued by the project as an instrument of federal law, under the alias *Investigational New Drug*. The project's at-issue entry describes it as "the federal filing that makes a drug trial lawful."[^1] The IND appears in the Minnesota record through one at-issue entry. That entry states that in May 2021 the U.S. Food and Drug Administration issued [[warning letters]] to two [[Hennepin Healthcare]] physicians for conducting ketamine and sedation studies on patients "without submitting Investigational New Drug applications." The entry identifies Hennepin Healthcare as the county's public hospital.[^1] The entry lists two agency sources on fda.gov, but neither is carried in the record compiled here. The record therefore does not establish the letters' text, their specific dates, the physicians' identities, or any response by Hennepin Healthcare.[^1] The entry is anchored to a March 2025 White House presidential action on eliminating information silos. The project cites that action for the point that research conducted outside the federal filing system is research outside the record.[^2] ## Who - According to the at-issue entry, the letters went to two physicians at Hennepin Healthcare, in [[Hennepin County, Minnesota]]. The entry does not name them.[^1] - The issuing agency is the U.S. Food and Drug Administration.[^1] ## What - According to the at-issue entry, the research at issue consisted of ketamine and sedation studies on patients.[^1] - The entry states that the warning letters were issued because no IND applications had been submitted for those studies.[^1] ## When - May 2021 is the month given for the FDA warning letters in both the entry's year field and its text. No specific day is recorded.[^1] - The entry's anchor, the White House presidential action, is dated March 2025.[^2] ## In the at-issue record - **AI-071 / AI-Hennepin-071 (Hennepin package).** The record holds this entry in two identical rows. The entry states that in May 2021 the FDA issued warning letters to two Hennepin Healthcare physicians for ketamine and sedation studies conducted without IND submissions. Its anchor is the March 2025 presidential action.[^1][^2] The catalogue page is [[At issue 071 - In May 2021 the FDA issued warning letters]]. ## Notes [^1]: Minnesota wiki at-issue record, *AI-071 / AI-Hennepin-071* (Hennepin package, 2021 entry) — the entry's text stating May 2021 FDA warning letters to two Hennepin Healthcare physicians for ketamine and sedation studies without IND submissions. The entry lists two fda.gov agency sources, but no source URL is carried in this record. [^2]: The White House, *Stopping Waste, Fraud, and Abuse by Eliminating Information Silos* (March 2025) — presidential action serving as the at-issue entry's anchor. https://www.whitehouse.gov/presidential-actions/2025/03/stopping-waste-fraud-and-abuse-by-eliminating-information-silos/