FDA’s Accelerated Approval (AA) pathway has often been a subject of public criticism due to the apparent approval of inefficient drugs based on preliminary and/or partial efficacy data. However, the AA is a conditional approval that can be withdrawn if the conditions are not met. This week, the FDA released a new guidance document whose … Read more
Medical devices containing Artificial intelligence (AI) and Machine Learning (ML) technologies inherently require updates as the software self-trains on the data generated internally, improving their performance over time which, in turn, triggers the threshold of a new 510k or a PMA amendment creating regulatory burden for the manufacturer. A new FDA guidance document provides a … Read more
The U.S. Food and Drug Administration (FDA) recently released two reports outlining its strategies for improving communication with stakeholders and developing guidance documents. The report on communications lists seven ways the FDA communicates with stakeholders, while the report on guidance documents describes the process to create new or update guidance documents, standardized format, and review … Read more
The number of cell and gene therapy (CGT) products has increased steadily over the last decade using traditional product development guidance documents. Although the FDA has released about 37 guidance documents governing the requirements for these products, developers frequently need additional help to define the specific non-clinical, clinical, and manufacturing requirements. A new FDA Guidance … Read more
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
