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 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 […]
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 […]
Today, the FDA issued a new immediately effective guidance entitled “Control of Nitrosamine Impurities in Human Drugs” that replaces the initial guidance by the same name that was issued on February 24, 2021. The new guidance can be found here. The industry has been awaiting the issuance of this revised guidance and the “FDA made […]
The one-day event will explore how to achieve and maintain good relationships with your Contract Manufacturer Organisation (CMO) Partners. Key industry leaders will share their perspectives on many topics such as the selection of a service provider, regulatory trends, and how to foster collaborative synergies when outsourcing. Lachman Consultants (Ireland) provides a full range of […]
In case you didn’t have the opportunity to attend the GRx+Biosims 2023 conference or were there and want to revisit the featured panel on nitrosamine impurities, here’s a quick recap and a link to the full Contract Pharma article, authored by Jennifer Leaming, Principal Consultant, Lachman Consultants. Four presentations were made by FDA representatives on […]
The session on nitrosamine impurities was held during the final breakout session on Wednesday morning during the final day of the conference. This session had the largest panel by far of those assembled on any topic presented at the conference, with 15 total panelists including the session moderator! It was even more difficult than usual […]
