ChatGPT can revolutionize the medical note taking process for clinical practices but it can exert unpredictable effects on clinical decision making by introducing nuances. A perspective in a recent publication in the Journal of American Medical Association (JAMA) provides a few pointers to what developers and practitioners must plan for when using ChatGPT or similar … Read more
FDA announced this week that it has noticed trends of fraudulent activities at non-clinical testing vendors located in India and China and warned the sponsors to be vigilant about using such data. Although the FDA did not name any specific vendor or devices that were affected, this raises an important issue for vendor selection and … Read more
Clinical trial sponsors are responsible for paying for the cost of conducting the trial which includes paying for the use of clinics, hiring staff or vendors to manage the trial, collection and review of the data, regulatory approvals, and anything else that may be needed to properly run the trial. In some specific circumstances, a … Read more
Since its first Guidance Document for Data Monitoring Committees (DMCs) in 2006, the role of DMCs in clinical trial and clinical development programs has expanded exponentially. Sponsors frequently debate the purpose, scope, and limitations of DMCs which in turn increases the time and cost to set-up these and creates confusing practices for their activities. Hence, … Read more
The concept of quality by design (QbD) has been used primarily in the context of GMP compliance. However, the FDA expects that this concept should be used in other compliance areas as well, particularly clinical trials. FDA and Duke University recently held a workshop describing various aspects of clinical trials that could be improved by … Read more
This week the US House of Representatives held a hearing on the lack of foreign on-site GMP inspections by the FDA where representatives from the GAO and other stakeholders including a “star witness” from India, presented their concerns about the quality of drugs imported into the US. The speakers and the committee members seemed to … Read more
It has been required since 1998 that race and ethnicity information be presented with clinical trial results included in market approval applications for all FDA-regulated products. However, there exists signification confusion about the specific demographic sub-groups that should be collected and the standardized approach that should be followed leading to variability in the reported data. … Read more
In a change more than 20 years in the making, the FDA released the final rule for good manufacturing practices (GMP) for medical devices this week. Although most of the changes incorporated into the final quality systems (QS) regulations have been practically implemented through various policies over the last decade, the final rule contains a … Read more
The FDA announced a major reorganization of its Office of Regulatory Affairs (ORA) which currently leads all FDA audits, litigations, and enforcement actions to reorganize its staff involved with food facility inspections from those involved in drug, biologic, and medical device inspections. The regulated industry needs to be aware of this reorganization, even though the … Read more
About 2 months after the first public reports of T-cell cancers linked to CAR-T therapies, the FDA finally decided to put a Box warning on all approved CAR-T therapies for unexpected malignancies. At the same time, the FDA also raised new expectations from CAR-T therapies in development, particularly those for indications outside hematology and oncology. … Read more
