“StemCells, Inc. has no further comment on the ongoing litigation or Mr. Williams’ allegations.”
“We can't comment on pending cases.”
“As a matter of policy FDA cannot comment on whether or not we are investigating or have plans to investigate any allegations.”
“Participation in any clinical trial is associated with some level of risk as the safety of investigational products has not been fully assessed. FDA’s primary responsibility is to determine whether the theoretical risks of the proposed study are reasonable and acceptable in order for the study to proceed “It is the responsibility of the study sponsor to conduct an investigation properly, to ensure proper monitoring of the investigation and to ensure that the investigation is conducted in accordance with the general investigational plan and protocols contained in the Investigational New Drug (IND) application. The sponsor also ensures that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the product being studied.
“Additionally, the individual who actually conducts the clinical investigation (i.e. the investigator) is responsible for ensuring that the trial is conducted according to the signed investigator statement, the investigational plan, and applicable regulations. The investigator is also responsible for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.
“In certain situations in which FDA alleges a clinical investigator has violated applicable regulations, FDA may initiate a clinical investigator disqualification proceeding. FDA does maintain a publicly available database that provides information about disqualification actions. Further background related to this topic is available at: http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm”