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The European Medicines Agency published a draft proposal to accept measurements of fibrinogen as a biomarker to identify chronic obstructive pulmonary disease patients for inclusion in clinical trials. Read More
Scott Gottlieb was grilled by a Senate panel over his support for the FDA’s approval standards, as well as his willingness to stand up to his future boss, President Trump. Read More
The European Medicines Agency is seeking applications to join a multidisciplinary team to help the agency develop best practices for the anonymization of clinical reports. Read More
The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource — the staff of its Office of Good Clinical Practices. Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Read More
The U.K.’s Information Commissioner’s Office published a draft guidance on obtaining informed consent, ahead of stricter European Union regulations on data protection that take effect in May 2018. Read More
An NIH center announced that all clinical trial sites participating in its grant program have agreed to use a single institutional review board for each multi-site study. Read More
Pharmaceutical companies and clinical research organizations are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. Read More