iwewlkws The final FDA guidance on risk-based monitoring (RBM) for clinical trials released this week expands on the advice given in the draft guidance from almost 10 years ago with a goal to reduce overall in-person site monitoring visits and increase reliance on centralized remote monitoring. Overall, this is not new information but confirmation of prevailing … Read more
About 10% of new drugs approved by the FDA between 2018-2021 failed their primary endpoints in one of more pivotal clinical trial but were still approved based on success in at least 1 other pivotal study, positive findings from secondary or exploratory end points in the pivotal study, or favorable post hoc analysis. Before we … Read more
A clinical trial may terminate early for a number of reasons unrelated to the safety of the investigational product. A survey of informed consent documents found that most of them do not acknowledge the possibility of early termination of the trial and the potential direct or indirect consequences for the participants for the same. Should … Read more
Since the beginning of the pandemic, there has been an acute shortage of monkeys for non-clinical research. Recently, due to increase in smuggling of long-tailed macaques, federal regulator started blocking imports from Cambodia, further aggravating the shortage of animals and a resulting increase in the cost and delays in research. But how big is this … Read more
Medical devices with software that connects to the internet and creates a potentially unaddressed cybersecurity vulnerability will be rejected by the FDA, starting 29 March 2023. The policy, which has been tacitly in effect since 2014 via Guidance Documents, is now being formalized into a Refuse-to-File (RTF) criteria. So, what’s new here? Many medical devices … Read more
This week FDA updated its Medical Foods guidance to clarify and expand on its previous guidance from 2016. The main update is regarding the requirement for allergen warning on medical food labels but there are several other pointers in the guidance about medical foods to answer common questions from consumers and industry alike. Medical foods … Read more
FDA allows animal drug approvals based entirely on published literature provided the selected publications adequately justify the specific claims in the market approval application and meets well-established scientific quality standards. Published literature lacks several quality standards essential for regulatory acceptance as sole evidence. FDA’s latest guidance on the topic lists those challenges and suggests ways … Read more
Electronic Records are an integral part of clinical practice and hence also of clinical trial source documents. In its 2017 Guidance on using electronic records in clinical trials FDA provided several suggestions on best practices for sponsors and clinical research organizations. This week FDA released an updated Guidance that expands on the original guidance to … Read more
Over the last 3 decades, expanded access or emergency use treatments have become quite common and clinical experience from expanded use of investigational products has even been used to provide additional safety data to the FDA and enrich the real-world evidence (RWE), particularly for rare diseases. But use of expanded access protocols also raises concerns … Read more
Use of Artificial Intelligence (AI) is being explored for several aspects of manufacturing FDA regulated products which raises new concerns that must be considered according to a Discussion Paper released by FDA this week. FDA would like the industry to comment on these concerns so suitable regulatory policies can be created for such systems. There … Read more
