The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
Clinical trial sites should determine their compatibility with central institutional review boards, including whether software they use to interface with the local IRB is capable of handling an outside review board, an expert says. Read More
Canadian biotech company Tekmira will restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, following the FDA’s downgrading of a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
Consumer advocacy watchdog Public Citizen is calling for an in-depth investigation of alleged human subject protection violations at the University of Minnesota between 2011 and 2014 and revocation of the university’s human subjects research credentials. Read More
The Office of Human Research Protections’ recent proposal to classify risk-comparison trials as “greater than minimal risk” will force physicians and patients to engage in overly burdensome informed consent processes that are out of proportion to the scope of the trials themselves, a leading bioethicist says. Read More
The European Medicines Agency appears to be backing off promises to protect industry trade secrets in its new clinical trials database, and is developing scenarios under which it would release commercially confidential information. Read More
Experience levels of principal investigators fluctuate wildly the world over, a fact that could put promising research at risk, according to a Tufts University report on protocol noncompliance rates and principal investigator turnover. Read More