Ethics/Regulatory

E.U.’s Safe Harbor ruling hits global trials

Monday, October 26, 2015

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.

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goBalto complies with European trial regulations

Wednesday, October 21, 2015

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.

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Obama signs improved compensation bill for rare-disease clinical trial participants

Monday, October 19, 2015

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.

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FDA expedites drug/biologic development and approval

Thursday, October 15, 2015

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.

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FDA voices concerns about its expanding mission

Monday, October 5, 2015

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.

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FDA warns Sironis for unapproved trial

Monday, September 28, 2015

The FDA has sent a warning letter to Sironis, a medical devices and software developer, for running an unapproved clinical trial of its LIR closed-loop fluid administration system. The FDA said the Newport Beach, Calif.-based company never sought the proper approvals.

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