FDA clinical trial tables

FDA clinical trial tables

The U.S. Food and Drug Administration (FDA) is informing the public that a recent clinical trial with Doribax (doripenem) was stopped early because of significant safety concerns. This trial, which was evaluating the effects of Doribax on treatment of…

SoCRA FDA clinical trial requirements

SoCRA FDA clinical trial requirements

Please Note: This enrollment registers you in the SOCRA FDA Clinical Trial Requirements Regulations, Compliance and GCP Conference. SOCRA REGISTRATION POLICIES/INFORMATION: Non member fees include a one year membership in SOCRA. Membership fees are processed…

FDA clinical trial IND

FDA clinical trial IND

When proposing an expanded access IND application for treatment of groups (or populations) of patients, an applicant should ensure that their proposal meets the criteria for expanded access applications described in the Expanded Access IND Application:…

FDA clinical trials for HIFU

FDA clinical trials for HIFU

A phase clinical study for AblathermĀ® HIFU, sponsored by EDAP TMS Inc. has been initiated in the United States. Patients diagnosed with low risk localized prostate cancer were recruited into the study. The recruitment phase of the study is complete and…

PureGen FDA clinical trials

PureGen FDA clinical trials

Tower Orthopaedics is the principal investigator in eleven clinical trials that attempt to develop new, effective treatments for herniated discs, degenerative disc disease, stenosis and scoliosis. We offer the newest technologies in Artificial Disc Replacement…

FDA clinical trials requirements

FDA clinical trials requirements

FDA Regulations Relating to Good Clinical Practice and Clinical Trials Get e-mail updates when this information changes. FDA regulations governing the conduct of clinical trials describe good clinical practices (GCPs) for studies with both human and non-human…