I sat in on the AI session at ARM’s Cell & Gene Meeting on the Mesa this week, and Steven Oh, Director, Office of Cellular Therapy and Human Tissue, US FDA, said something that stuck with me: “AI has a lot of promise, but there are a lot of challenges ahead.” He also spoke to […]
A significant FDA reorganization is scheduled to be published in the Federal Register on July 29, 2026 (see here). The proposal is one of the most extensive administrative restructurings the agency has undertaken in years and is intended to “centralize and enhance key functions across the agency” to “reduce redundancies, improve efficiency, and advance alignment […]
Dr. Marty Makary resigned today as FDA Commissioner, marking another leadership transition for an agency that continues to face pressure across drug reviews, inspections, compliance, and broader public health policy. For pharmaceutical and biotech companies, changes in FDA leadership always raise questions about regulatory priorities, review timelines, and enforcement focus. While leadership shifts can influence […]
In today’s pharmaceutical environment, remediation following FDA enforcement action has become more complex, data-driven, and scrutinized than ever before. Recent trends, including a holistic view and an increased focus on data integrity, digital system validation, supply chain oversight, and quality culture, have raised the bar for what constitutes an effective and sustainable remediation program. Companies […]
What began as a concept previewed earlier this year has now become official policy. Today, the U.S. Food and Drug Administration (FDA) announced the launch of its “One-Day Inspectional Assessments” program, formalizing a new inspection model aimed at certain low-risk facilities (here). Under the initiative, qualifying sites may undergo a streamlined, single-day inspectional assessment while […]
There’s always a certain energy at PDA Week – the kind that comes from a shared sense that our industry is moving, sometimes faster than we expect. This year in Denver, that energy felt different. More focused. More urgent. And in many ways, more practical. As both an exhibitor and attendee representing Lachman Consultants, I […]
Pharmaceutical Technology has featured Charlie Gibbons, Director of Compliance at Lachman Consultants in an article, AI and Digital Oversight in Pharma Supply Chains: PDA Regulatory Conference Insights, following his recent presentation at the PDA Global Regulatory Conference. In his session at the conference, Charlie provided valuable insights into today’s evolving regulatory landscape, highlighting the practical […]
In the realm of pharmaceuticals, navigating the intricate landscape of facility and Quality Management System (QMS) remediation following FDA enforcement actions demands precision, foresight, and a commitment to sustainable change. When faced with regulatory scrutiny, it is imperative for companies to not only address the identified issues but also to comprehensively understand the root causes […]
As a proud Silver Sponsor of this important conference, we’ll be looking for you at Access! 2024. This annual meeting of the Association for Accessible Medicines (AAM) is happening in Tampa, Florida at the JW Marriott from Monday, February 5th through Wednesday, February 7th, 2024. Visit with us at Booth #11. The Lachman Consultants team […]
With 2024 coming up fast, we thought it would be good to look back at some of the more impactful changes to the quality landscape that came about this past year. Here are just some of the stories from the Lachman blog that exemplify a productive year 2023 for our industry. Get Ready for […]
