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 […]
The Generic Drug Forum was a two-day event held on April 8-9, 2025. This was one of the first public engagements that the Office of Generic Drugs (OGD) participated in since the current administration’s pause on FDA communications was announced in February 2025. There were many interesting sessions that presented an enormous amount of content. […]
Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust. Imagine […]
The recent bankruptcy announcement of 23andMe is a classic case study in data ownership – not necessarily what should happen, but what actually does happen! Open and transparent discussion about data ownership is sometimes easier if the situation is not strictly a GxP issue, but the learnings and analogies in a QMS or PQS should […]
On October 26, 2020, a business plan was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) that eventually resulted in a holistic revision to ICH Q9, “Quality Risk Management,” the “R1” of the framework. The four areas of concern were identified as: High levels of subjectivity in risk assessments […]
Today, I read an article in Dickinson’s FDA Webview (here; subscription required) titled “Clinical Researchers Plead Guilty to Fraud” that has the following rather chilling opening line: “Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with their work on two clinical trials testing drugs […]
Deflecting responsibility is a timeless tactic for the young. While it was easy to simply point the finger and say, “I didn’t do it, they did,” as children, this approach is not viable in the life-sciences industry when things go awry. In this sector, we can’t simply transfer our responsibilities without written agreements and clear […]
In an era of rapid technological breakthroughs, the incorporation of artificial intelligence (AI) into numerous industries is transforming the way in which we all work. AI has been shown to be a valuable tool for automating mundane processes and analyzing large datasets. However, as we embrace its potential, we must also address the cybersecurity threats […]
