The FDA’s April 2, 2026 Warning Letter to a cosmetics company marks a defining moment for the regulated industry, not because artificial intelligence (AI) was used in this firm’s operations, but because it was deployed without effective governance within a Pharmaceutical Quality System (PQS). In this case, management relied on AI agents to draft GMP-critical regulatory […]
If GMP already accommodates AI, the next challenge is practical execution. The goal is not to “add AI compliance,” but to embed AI into existing quality systems with intent and discipline. Part 2 of this series (here) unconsciously introduced the often-misunderstood concept of “critical thinking,” which is easy to say, but difficult to perform in […]
The prevailing industry narrative around artificial intelligence (AI) governance often presumes that we are entering fundamentally uncharted regulatory territory—territory that will necessitate entirely new compliance architectures. The recent FDA–EMA guidance “Guiding Principles of Good AI Practice” suggests otherwise. It reinforces a more pragmatic conclusion: the existing global GMP framework already provides the structural foundation necessary for […]
Overview of Regulatory Alignment The recent joint FDA–EMA guidance “Guiding Principles of Good AI Practice in Drug Development” has sparked conversation across the industry. Do you view it as a major shift or dismiss it as “just another guidance”? The truth usually sits between those extremes. This blog series will examine the signals, which we […]
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 […]
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, […]
The AI Action Plan was initiated by Executive Order (EO) 14179, signed in January 2025, which directed the federal government to remove barriers to AI innovation and develop a national strategy. Following a public consultation that generated over 10,000 comments, the plan was released in July 2025 with input from industry, academia, and government stakeholders. […]
A recent report in Nature Medicine (published February 17, 2025) highlights the long-term potential of Chimeric Antigen Receptor T Cell products (aka CAR-T cell therapy), showcasing an exceptional 18-year remission in a neuroblastoma patient. This milestone is particularly significant given the historical challenges that CAR-T therapy has faced in effectively treating solid tumors like neuroblastoma, even while […]
The pharmaceutical industry is entering a transformative era with the Food and Drug Administration’s (FDA) newly established pathway for nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU), with the final rule announced in a December 2024 Federal Register Notice (here). This new rule aims to broaden consumer access to safe and effective […]
