On 19 July 2012, after a second evaluation which involved the adoption of a formal opinion of the Agency’s Committee for Advanced Therapies (CAT), the[…]
Numerous terms, all with subtle differences in meaning, are used to refer to the undesirable occurrences commonly referred to as adverse events. An article in[…]
Numerous terms, all with subtle differences in meaning, are used to refer to the undesirable occurrences commonly referred to as adverse events. An article in[…]
A study by Medidata Solutions suggests that up to 20% of clinical trial budgets go to pay for procedures that are not directly related to[…]
FDA is currently seeking public comments regarding its Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually[…]
According to a notice in today’s Federal Register, the National Institutes of Health (NIH) is seeking public comments on a proposed video game to educate adolescents[…]
An article by Matthew Herper of Forbes.com raises questions about the independence of data safety monitoring boards (DSMBs), and the potential for trials of promising[…]
According to research presented earlier this week at the annual meeting of the American Society of Clinical Oncology, an annual income of less than $50,000[…]
A group of pharmaceutical companies has issued a list of recommendations for improving the transparency and credibility of industry-supported clinical research. The recommendations include: Making all[…]
The California state legislature is currently considering a bill known as the Genetic Information Privacy Act. The bill includes very specific requirements for informed consent to[…]