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 […]
Digital resilience is a concept that often needs to be revised and redefined within an organization. The pharmaceutical industry can be slow at times to identify potential external risks and assess the potential impact to operations. Much of the work we do here at Lachman helps regulated industry anticipate and mitigate Quality Management System risks […]
Elizabeth Miller, Associate Commissioner for Inspections and Investigations, provided an update on the FDA’s Office of Inspections and Investigations (OII). She noted that the government shutdown has impacted the OII’s core activities which include inspections, investigations and imports. She noted that the lapse in appropriations has resulted in the need for risk-based prioritization of OII’s […]
Have You Used These Terms Before: Monitoring, Governance, Auditing? Are they the same? Are they different? Are they related in some cryptic way, but you find it difficult to explain? Can anyone execute them? Do they require different skill sets? Understanding the differences between these roles is essential for professionals working in regulated environments, such […]
The move to link inspectors to specific organizational units (i.e., drugs, devices, biologics) to more closely align with the Centers responsible for the products seems to have taken a turn back to a more generalist approach. According to a Pink Sheet article (here, subscription required) authored by Sarah Karlin-Smith and Derrick Gingery, the so-called “‘Simple […]
Congratulations! Your firm has just successfully manufactured a high-quality pharmaceutical or biological product and is ready to ship it to the next destination to get it into the hands of the people who need it. Take a moment… is your firm REALLY ready? Your firm’s product is either starting its journey in a global supply […]
The FDA’s new guidance on Computer Software Assurance or CSA (here) marks a shift—one that prioritizes critical thinking, product quality, and patient safety. In the world of regulated life sciences, the validation of software has long been guided by strict requirements. For decades, companies followed traditional Computer System Validation (CSV) approaches, often focusing on generating extensive […]
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 […]
According to an FDA bulletin (here), “the FDA is sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.” A copy of the letter warning firms to remove misleading ads can be downloaded here. The bulletin says, “The FDA is concerned patients are […]
Yesterday, the FDA quietly posted another update to the CDER Nitrosamine Impurity Acceptable Intake Limits webpage. The latest update is not an extended timeline for submitting changes or new acceptable intake (AI) limits as might be expected but instead because CDER has become aware of an emerging issue related to small-molecule nitrosamine impurities such as […]
