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The FDA invited comments from stakeholders on a new draft guidance for clinical trial designs and drug development programs to support indications for uncomplicated urinary tract infection (uUTI) treatments. Read More
The market for clinical trial management system software is expected to be worth nearly $1.8 billion by 2019 with much of the double-digit growth taking place in developing countries, according to Persistence Market Research. Read More
Amid the push among House and Senate Republicans to pass a sweeping tax reform bill, clinical researchers called on the federal government to modernize the research and development tax credit. Read More
Because of delays in implementing the EU regulation, the UK’s compliance with future EU clinical trials rules will likely be subject to negotiation, as the country plans to only immediately implement EU regulations that were in place ahead of the planned March 2019 exit from the EU, according to a UK government official. Read More
Clinical researchers can use mobile technologies to improve the trial process if they focus on patient-centric measures and engagement with regulators, according to the Clinical Trials Transformation Initiative (CTTI). Read More
The use of risk-based monitoring in clinical trials is expected to climb — with many sponsors planning to implement policies for the first time over the next two years — driven by the need to reduce oversight costs and mitigate risks. Read More