Sunday, November 1, 2015
Although shorter informed consents, greater use of central IRBs and broader biospecimen consent for unspecified future research were among the possible changes outlined by the Department of Health and Human Services (HHS) in its recent notice of proposed rulemaking for human subject research protections, not all IRBs are fully on board.
Europe’s highest court has struck down an international agreement allowing companies to move digital information such as people’s Web search histories and social media updates between the E.U. and the U.S.
The decision could have an impact on global clinical trials and on U.S. pharmaceutical companies that are expanding to use international sites for that patient population.
San Francisco-based goBalto, a provider of cloud-based clinical study startup solutions, has announced compliance with new European regulatory directives aimed at creating an environment that is favorable for conducting clinical trials across the European Union.
Two hurdles were cleared for a relatively small number of clinical trial participants when President Barack Obama signed the Ensuring Access to Clinical Trials Act of 2015. The legislation enables individuals with rare diseases to receive up to $2,000 for participating in clinical trials without having that compensation counted as income when calculating eligibility.
The FDA has created four mechanisms to expedite development and approval of drugs and biologics that effectively treat serious diseases: Accelerated Approval, Breakthrough Therapy Designation, Priority Review and Fast Track Designation. Understanding the requirements and benefits of each can inform decisions for your development program.
More than 40% of GPs view the pharma industry negatively and many believe that it misunderstands their key challenges and working practices, a survey by healthcare data and intelligence provider Binley’s has found.
The Medicines and Healthcare products Regulatory Agency (MHRA) has signed a Memorandum of Understanding (MOU) with its counterpart body in India. The agreement will increase collaboration between the two countries in the area of medicines and medical devices with the aim of further improving public safety.
Citing how its mission continues to be “at risk,” the FDA—in a new report from its Science Board—said the agency’s expansion and extraordinary range of increasingly complex responsibilities and insufficient resources needs to be addressed soon.
Attorney General Joseph Foster has launched an investigation into the manner in which several pharmaceutical companies have marketed prescription opioids in New Hampshire.