Oeyama-Moto is back in the hot seat after the agency accused the company of violating a clinical hold the agency had placed on a clinical trial.
The letter posted last week accused the organization of administering drugs to six patients on two separate occasions in May 2014, when the agency placed a clinical hold on the company’s trial efforts. The agency did so because the trial posed an “unreasonable and significant risk” to patients due to a lack of risk assessment information, a deficient protocol and a “misleading, erroneous” or unfinished brochure, the letter said.
The warning letter contends that two subjects were given an investigational drug on May 3, 2014, and four subjects received the same drug on May 7, 2014. However, Oeyama said in a conflicting statement that it agreed not to resume the study without FDA notification. The hold was eventually lifted in 2014, but not before the company resumed trials, the letter claims.