We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Drug companies conducting clinical trials in India would be required to pay significant compensation for the deaths of some subjects during a study, under a rule released May 29 by the Central Drugs Standard Control Organization. Read More
Sponsors attempting to reduce R&D costs and inefficiencies through joint and risk-sharing clinical development programs may actually spend longer in development, a new report says. Read More
Manufacturers conducting clinical trials in India would be required to pay significant compensation for deaths of some subjects during a study, under a rule released last week by the Central Drugs Standard Control Organization. Read More
Drug companies conducting clinical trials in India would be required to pay significant compensation for deaths of some subjects during a study, under a proposed formula released last week that lays out the conditions and amounts of payment. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More
Institutional review boards (IRBs) that assume oversight of a clinical trial from another IRB should give drugmakers an opportunity to address any concerns the receiving IRB has with the study before it is terminated or suspended, the FDA says in a final guidance that makes only minor tweaks to the 2012 draft. Read More
Devicemakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s 1945 Drug and Cosmetic Rules are adopted. Read More
Devicemakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s 1945 Drug and Cosmetic Rules are adopted. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More
FDA inspectors berated a clinical investigator at New York’s Columbia University Medical Center for failing to properly oversee a clinical trial, despite the university having shut down the study after discovering the violations. Read More
The European Medicines Agency has backed off of several controversial limitations it was considering imposing on sponsors of trials for treatments for chronic primary immune thrombocytopenia. Read More
Advocates for minorities and other patient groups that are underrepresented in clinical trials want the FDA to create incentives for drugmakers that include those groups in studies and become more aggressive in delaying drugs that don’t include them. Read More