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The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them to a researcher, setting up a test case for the EU’s new trial transparency policy. Read More
The Office of Human Research Protections’ recent proposal to classify risk-comparison trials as “greater than minimal risk” will force physicians and patients to engage in overly burdensome informed consent processes that are out of proportion to the scope of the trials themselves, a leading bioethicist says. Read More
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued March 3 by the Central Drugs Standard Control Organization. Read More
Sponsors of clinical trials that rely on data from x-ray and other images should send those images to a centralized reading facility to prevent accidental unblinding or bias that may occur at trial sites, the FDA says. Read More
Drugmakers designing trials for alcoholism treatments can use a primary endpoint of no heavy drinking rather than total abstinence, the FDA says, in an acknowledgement that abstinence as a goal in these studies is often unattainable. Read More
Clinical trial sites using software to obtain patients’ informed consent remotely should make sure the data is stored securely, the FDA says. Read More
The FDA Tuesday outlined new deadlines and procedures for the way drugmakers seek and conduct meetings with the agency before and during reviews of new product submissions. Read More
Spanish regulators are investigating Pfizer sales contracts for possible anticompetitive conduct, following a Supreme Court ruling in November that the drugmaker’s dual-pricing contracts could restrict parallel trade in the EU. Read More