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The number of clinical trials in India is rebounding after plunging precipitously in recent years following the government’s imposition of strict new regulations on the clinical trial industry. Read More
Indianapolis oncologist Ruemu Birhiray was hit with an FDA warning letter after investigators uncovered multiple procedural failures at his clinical trial site. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More
The European Medicines Agency is looking into potential heart risks linked to testosterone-containing drugs after an EU member state regulator raised safety concerns. 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 FDA and India’s Ministry of Health and Family Welfare signed a five-year accord that will allow them to share information from clinical trial inspections in their respective jurisdictions. Read More
Institutional review boards that fail to write explicit policies defining clinical trial noncompliance are putting themselves and their research sites at risk, an industry expert says. Read More
The FDA is proposing that physicians be allowed to perform fecal matter transplants (FMT) in limited circumstances without an investigational new drug (IND) application, provided the physician or their patient knows the donor. Read More
Vaccine trial sponsors should report study-related fatalities within seven days of an event and submit follow-up reports by eight days later, a recent China Food and Drug Administration guideline says. Read More
The IRB at a major Chicago hospital has been handed an FDA warning letter for a slew of violations in a device clinical trial, many of which were first observed at the site over a decade ago. Read More