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.
The agency said the testimonials do not “adequately support the suggestion in the presentation that other patients switching to Livalo from other statins will experience a similar reduction in side effects.”
Amgen is facing more bad news regarding possible off-label uses of its drug Aranesp, after independent study results pointed to adverse outcomes for a certain class of cancer patients prescribed the drug. Read More
A new report by the UK’s Royal Statistical Society (RSS) proposes sweeping reforms aimed at minimizing the risk to volunteers in drug trials, maximizing design efficiency and enhancing scrutiny of clinical trial protocols.
A key committee is recommending that the Centers for Medicare & Medicaid Services (CMS) soften a controversial proposal to require clinical trials it covers to enroll representatives of the populations Medicare serves.
All “unanticipated problems” affecting participants in clinical trials sponsored or supported by the U.S. Department of Health and Human Services must be reported, a new guidance from the Office for Human Research Protections (OHRP) says.
A UK governmental commission has called for the establishment of an open-access database of information for certain high-risk Phase I clinical trials, along with 21 other recommendations that are intended to prevent any repeat of the catastrophic Phase I clinical trial of gene therapy TGN1412.