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Clinical research organizations foresee specific technologies redefining trial design, but also posing data integrity risks due to minimal FDA guidance. Read More
The FDA wants clinical researchers to improve their electronic data capture systems to ensure interoperability with electronic health records used by healthcare organizations. Read More
France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Read More
The Secretary’s Advisory Committee on Human Research Protections is recommending the FDA revise its informed consent waivers for cluster randomized trials to mirror HHS rules. Read More
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements. Read More
The Secretary’s Advisory Committee on Human Research Protections is recommending revisions to the Common Rule that would provide further guidance on single IRB reviews. Read More
The U.S. Government Accountability Office faulted the FDA’s approach to regulatory science and its strategic management plan in two reports the agency issued Wednesday critical of the agency. Read More
A former FDA official has been hit with insider-trading charges by the Securities and Exchange Commission for supposedly sending confidential information about FDA approvals to a hedge fund manager. Read More
British authorities are ordering a U.S. manufacturer to recall drug batches, suspend clinical trials and cease distribution after an inspection uncovered critical GMP violations. Read More