he Center for Veterinary Medicine (CVM) at the FDA has been accepting applications for new products electronically for a few years. But since CVM applications and documents follow a very different format compared to those for the human drugs and biologics, it has been confusing for companies to understand the acceptable electronic submission process. A … Read more
More than half of the cancer drugs are approved by the FDA based on non-randomized single-arm trials using surrogate endpoints. Also, many drugs for ultra-rare diseases with few or no options are approved based on open-label studies since including a placebo or a standard of care control arm is not feasible or ethical in those … Read more
Medical device manufacturers need to re-access if their device’s FDA approval or clearance is still valid upon making modifications to the device. Not doing a proper assessment could lead to FDA deeming the device illegally marketed. This hard lesson was learnt by Abbott’s Canadian unit selling a diagnostic test for quantitative measurement of cardiac troponin … Read more
The media frenzy driven by social media posts describing the off-label use of Ozempic and similar drugs for weight loss has seemingly caught the FDA off-guard. This is a classic case of where off-label promotion of a product by sources independent of the manufacturers has yielded excessive riches for the manufacturers. The hype around weight … Read more
The bankruptcy of Pear Therapeutics serves as a cautionary tale for the digital medicine industry. The Boston-based startup had raised over $200 million in funding, developed digital therapeutics for the treatment of substance use disorder and other mental health conditions, and got them through FDA approval. However, it was unable to yield returns it projected … Read more
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FDA guidance on risk-based monitoring (RBM) for clinical trials released this week expands on the advice given in the draft guidance from almost 10 years ago with a goal to reduce overall in-person site monitoring visits and increase reliance on centralized remote monitoring.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
