FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.
This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.
Not a day goes by when we don’t learn of yet another application for mobile phones in healthcare. The list includes using mobile phones to diagnose and manage health-related conditions, to monitor subjects participating in clinical trials, and to conduct remote consultations with physicians and other caregivers.
Since 1983, pharmaceutical developers have been incentivized by the FDA via an Orphan Drug Designation (ODD) program to develop products to treat rare diseases and/or conditions. The program awards orphan status to drugs that show likelihood of benefitting an afflicted population that might not otherwise be the focus of targeted development efforts. To meet the FDA’s specific requirements, sponsors have found specificity matters. Though other steps in a drug’s life cycle require a wider scope, when it comes to defining the orphan population and making a case for the drug’s potential efficacy in that population, a razor-focused effort is key.
The new year is just around the corner, signaling a fresh start and new beginning. Janus, the Roman god of new beginnings and namesake of the month of January, likely inspired our familiar tradition of reflection and resolution this time of year. Janus had two faces, which allowed him to look backward to the past and forward to the future.
Previous articles on Clinical Leader have discussed the potential benefits of wearable devices for remote patient monitoring in clinical trials. In addition to possible increases in trial efficiency and reduction of costs, “wearables” have the potential to collect data better reflecting patient functioning and response in the real-world setting. According to the Clinical Trials Transformation Initiative’s Mobile Clinical Trials (MCT) Program, mobile devices, including wearables, offer the opportunity to collect more complete and informative data than ever before. Mobile devices may also reduce the patient burden in clinical trials, thus enhancing the patient experience. Companies are exploring the use of wearable devices in the post-marketing setting as well, as a component of patient care.
Modeling and simulation (M&S) in the drug development process is an industry-proven scientific approach used to inform crucial drug development decisions such as dosing, drug-drug interaction (DDI), and other critical safety and efficacy questions. The FDA has shown a strong commitment to utilizing M&S in the drug development process.
The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.
Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.
A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.