The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) endorsed a new draft guidance on extractables and leachables in August 2025 that the FDA has since published for review and comment. The version published by the FDA is accessible at Q3E Guideline for Extractables and Leachables and includes Supporting Documentation: […]
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 […]
The FDA has announced the establishment of a public docket to receive comments on issues related to accelerating the establishment of new pharmaceutical manufacturing facilities in the US. You can read the full docket announcement here. Not only is the Agency opening a docket for comment, but that same announcement included information on a public […]
The FDA quietly posted an update to the CDER Nitrosamine Impurity Acceptable Intake Limits webpage yesterday. The latest update is unusual in that it is not an update to any of the posted AI limits, but rather the text added below Table 4 noting that the FDA is allowing additional time for submission of required changes […]
Lachman has blogged many times on the topic of nitrosamines over the last several years as the FDA has issued and revised guidances providing its recommendations for assessment and control of nitrosamine impurities. The published deadline for compliance with these recommendations is quickly approaching; it’s just over three months until the August 1, 2025 compliance date […]
As consultants we have the privilege of assisting many clients with FDA communications on a variety of topics and working with them to support many different types of drug product applications. Through our work we often identify common themes or issues that our clients are facing and one of the biggest headaches for our ANDA […]
In the latest CDER Science Spotlights, available (here), the FDA provides some insight into the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine recommended acceptable intake limits of N-nitrosamine impurities in drug products. The latest revision of the Nitrosamine Impurity guidance updated in September 2024 (here) provided better integration of the overall assessment […]
As Bob has previously blogged on the highlights from AAM day by day, let me take a moment to dive a bit deeper into one of the sessions. As an attendee of this meeting for several years, one of the best things about AAM’s GRx+Biosims is that sessions at this meeting often offer a mix […]
The FDA has updated the original nitrosamine impurity guidance after publication last year of Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (here), also known as the RAIL guidance, caused a few disconnects between the two guidances. Now that we’ve all had more time to carefully read and absorb the updates in the […]
The last blog that we drafted on this topic, The Curious Case of the Late Cycle Amendment under GDUFA III, was posted last summer (here). As a quick refresher on what we covered, the GDUFA III Commitment Letter (here) included several new enhancements to the Generic Drug User Fee Program, one of which was the inclusion of […]
