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Northfield Laboratories’ woes over the clinical trial of its blood substitute PolyHeme deepened as law firm Scott & Scott LLC filed suit
in U.S. District Court for the Northern District of Illinois, Eastern Division, on behalf of stockholders.
Sponsors of clinical trials in South Africa should provide special medical insurance to compensate participants if they suffer adverse effects, according to South African Health Minister Manto Tshabalala-Msimang.
The FDA is not prepared to accept all of the recommendations put forth by the Heart Rhythm Society (HRS) on tracking pacemakers and implantable cardioverter-defibrillators (ICDs) for potential malfunctions.
The FDA has issued a new guidance designed to help drugmakers identify compounds that could harm the immune system and provide direction on testing for such immunotoxicity.
Sponsors confronted with a clinical trial adverse event (AE) must also be prepared for scrutiny regarding how they selected and set up their data safety monitoring board (DSMB), expert Mark Barnes warned at an April 24 FDAnews audioconference.
The Heart Rhythm Society (HRS) has issued a series of recommendations for industry, the FDA and physicians to consider in revising the processes for postmarket surveillance and analysis of pacemakers and implantable cardioverter-defibrillators (ICDs).
The highly publicized health problems suffered by several participants in TeGenero’s UK-based clinical trial for TGN1412, an immune-boosting drug, have raised new questions about patient protection and informed consent issues in trials.