The FDA’s audits or inspections of manufacturing facilities are critical to ensuring the availability of high-quality regulated products to US consumers. The Government Accountability Office (GAO) has raised issues with FDA auditing practices over the years. GAO’s latest report highlights a practical reason that may be affecting FDA audits: the cadre of its inspectors. FDA … Read more
Designing non-clinical toxicity studies is challenging for any new product due to several guidance documents providing seemingly similar but different perspectives on regulatory requirements. This week the FDA released a guidance document describing strategies for non-clinical study plans for oligonucleotide products. More than 20 guidance documents describe the non-clinical study requirements for all drugs and … Read more
Patients trust their doctors for medical information. Previously it has been argued that the rampant misinformation on the internet about medical topics can be countered by patients conferring with their doctors. But what happens when that very source, the doctor, spreads misinformation? Do the medical boards, whose job is to regulate the medical profession, penalize … Read more
FDA’s top scientists published a review article in the Journal of American Medical Association (JAMA) reviewing the various uses of Artificial Intelligence (AI) and the regulatory trends and expectations. FDA acknowledges several current and potential uses of AI in drug development and clinical research, making these processes more efficient and precise. In drug development, AI … Read more
Clinical trials require controls and robust informed consent. However, ethicists argue if the one-size-fits-all approach should be customized to the perceived risk of a given trial. Should the trail risk be determined by the regulators and the information shared with the participants via the informed consent be reduced for lower-risk trials to encourage more investigator … Read more
Twenty years ago, the FDA halted all gene therapy clinical trials based on reports from France of cancers in children who received gene therapy. When last week, it was reported that deadly cancers emerged within 2 years in seven out of 67 children who received an FDA-approved gene therapy, the Agency took a wait and … Read more
Most discussions about the lack of diversity in clinical trials are focused on studies for drugs and biologics, not much is discussed publicly about the diversity of trial participants in medical device clinical trials. This week the FDA started publishing the “Device Trial Participation Snapshots” which shows important demographic trends for medical device clinical trials. … Read more
Institutional Review Boards (IRBs) are the surrogates of the FDA for regulating clinical trials by ensuring compliance by the investigators under their purview. But occasionally IRBs may falter in their responsibilities leading to negative audit findings. This is what happened with the IRB at Lousiana State University Health Science Center (LSUHSC) which was found to … Read more
The FDA has been rolling forward with the implementation of the new medical device rules whereby the Lab Developed diagnostic Tests (LDTs) will be converted to conventional In Vitro Diagnostic (IVD) devices or removed from the market. It is the responsibility of the manufacturers of LDTs to navigate the new regulatory environment. A new page … Read more
Electronic medical records and other electronic systems are ubiquitous sources of the source data for clinical trials. There is confusion and misinformation about the FDA requirements from such data particularly in pragmatic trials where the clinics participating in the clinical trial also provide health care services. FDA’s new guidance on the topics answers many common … Read more
