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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

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

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

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

Informed consents from patients/subjects are critical both in clinical care and clinical trials. However, informed consents are mostly written such that it would be hard for most patients to adequately understand them leading to improper informed consent. A study published this week reports on the experience of a clinical practice using ChatGPT to write/revise informed … Read more