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.
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.
Educating GMP laboratory analysts on good laboratory practices (GLP) goes a long way in reducing staff resistance to incorporating GLPs into GMP lab operations, according to Kristin Arpin, a quality assurance expert with Purdue Pharma.
Clinical sites must use care when billing Medicare for costs incurred in clinical trials, or they run the risk of being charged under the federal False Claims Act, which can result in criminal liability.
Because all FDA centers and various regulations are involved with combination products, whatever is happening with these devices will have an impact on all other products, said Mason Diamond, vice president of clinical and regulatory affairs for TyRx Pharma.