The Coming Wave of GLP-1 Competition The global success of GLP-1s has reshaped the metabolic disease landscape, driving unprecedented demand across diabetes, obesity, and adjacent indications. As key patents for leading products (such as semaglutide and tirzepatide) approach expiration in various countries, a new wave of companies, ranging from traditional generics manufacturers to complex peptide […]
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 […]
Mergers and acquisitions in the pharmaceutical industry are nothing new. CDMO consolidation has become prevalent over the last several years as well. More recently, however, a new and more complex dynamic has emerged: pharmaceutical companies acquiring CDMOs outright. A pharmaceutical company acquiring a CDMO represents more than financial consolidation. It fundamentally reshapes the quality, compliance, […]
When your company receives notification from the FDA that your most recent inspection is classified as “VAI” (Voluntary Action Indicted), does that mean that you’re off the hook and can relax until the next inspection? Absolutely not! The assignment of VAI spans the spectrum from almost NAI (No Action Indicated) (maybe one minor FDA Form 483 (483) […]
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 […]
From September 18 to 20, 2024, I was pleased to attend the PDA India Chapter conference on Quality Management Maturity and Supply Chain Resiliency, and I was impressed with the number of people who took three days out of (what must be) busy schedules and demanding jobs in the Indian pharmaceutical industry to attend. […]
CAPAs are one of the most important elements of the pharmaceutical Quality System. During Day 1 of the PDA/FDA Joint Regulatory Meeting, Jonathan Chapman, Senior Policy Advisor at the FDA, spoke about CAPAs. Traditionally, we think of CAPAs as follows: Corrective actions are actions implemented to correct an identified problem. Preventive actions are actions implemented to […]
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 […]
The beautiful country of Malta was the backdrop of the 28th Annual Medicines for Europe Conference for 2023. One of the key themes of the conference was assuring a consistent supply of essential medicines to all of Europe. This topic was at the heart of all the sessions. Pharmaceutical manufacturing in Europe has a rich […]
I recently attended the ISPE Annual Meeting, held October 29 through November 2, 2022 in Orlando, Florida. The conference had varied content in areas such as Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations. The conference was well attended by both industry and regulators. Although I found all of the […]
