The process of debarment began after the generic drug scandal in the late 1980s and the FDA continues to use this process to preclude individuals from participating in a variety of activities, including drug development, manufacture, clinical studies in support of drug applications, and importing drugs into this country if they are have been convicted […]
In the FDA-regulated industry, speaking up is a cornerstone of a mature quality culture. It refers to the reporting of deviations, risks, concerns, or unethical practices, whether related to product development, manufacturing, data integrity, or patient safety. When embedded in an organization, speaking up inherently increases detection of signals that are directly or indirectly indicators […]
With a new U.S. administration and leadership at HHS, regulatory priorities have evolved over the course of 2025. While the exact current and potential future priorities of the FDA may not be fully known at this point, one can expect continued focus on compliance, product quality, and supply-chain resilience, making it crucial for pharmaceutical and […]
In today’s regulatory climate, avoiding an FDA Form 483 after an inspection isn’t necessarily a sign of success, it’s the bare minimum. True industry leadership in Current Good Manufacturing Practice (cGMP) goes beyond damage control. It demands a proactive, risk-based approach to quality that starts well before the regulator arrives for an inspection. The finalization of […]
The ICH Q12 Guideline complements ICH Q8 to Q11 Guidelines and provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. The Q12 guideline highlights the need for an effective PQS as described in ICH Q10 and in compliance […]
While paper trails and legacy systems remain part of the landscape, pharma has been actively coding its next chapter: evolving through digital innovation, transforming core functions like drug development, manufacturing, regulatory oversight, and patient interaction. Central to this is the adoption of advanced technologies such as artificial intelligence (AI), blockchain, cloud computing, and digital twins, […]
Let’s admit it, whether in our personal or working lives, change is hard! As a species, we like to stick with the known and what works for us. Do many of us switch between Apple and Android devices? Is there a brand of car, beer, or wine that we favor? Why don’t we try other […]
Today, May 22, 2025, “[t]he U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid” (see the FDA announcement here). The two labs receiving the so-called General Correspondence Letters are […]
Today, the FDA announced the “Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities” (here), signaling that the Agency appears to be leveling the playing field between domestic and foreign facility inspections. According to the comments in the May 5, 2025 Regulatory Affairs Professionals Society (RAPS) Regulatory Focus article by Joanne S. Eglovitch (here), the “unannounced foreign […]
Firms will commonly espouse the virtues of a robust company culture as it relates to Quality. I’ve frequently heard the chant that “culture trumps strategy” when addressing the need to drive quality improvement plans. There’s a lot of credence with such a statement as culture is addressing (at a high level) a collective belief with […]
