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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
Clinical trial sites using software to obtain patients’ informed consent remotely should make sure that data is stored securely, the FDA says in Friday draft guidance on handling electronic informed consents. 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
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued Tuesday by the Central Drugs Standard Control Organization. Read More
The FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety and biosimilars development, and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research. Read More
A German regulator says European Medicines Agency plans for implementing its clinical trials database lets drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercial confidentiality. Read More