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# Nitrosamine CPCA Expedites Drug Approvals: FDA
- URL: https://www.fdaweb.com/nitrosamine-cpca-expedites-drug-approvals-fda/
- Published: 2025-01-14T12:00:00.000Z
- Updated: 2026-09-14T14:50:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158482

FDA says the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine an acceptable intake (AI) limit for N-nitrosamine impurities in drugs has expedited the regulatory review of drug safety assessments submitted by drug companies as an AI limit can be identified more efficiently and with greater transparency and predictability. An agency online [report](https://www.fda.gov/drugs/spotlight-cder-science/determining-recommended-acceptable-intake-limits-n-nitrosamine-impurities-pharmaceuticals?source=email) says FDA co-led the development of the CPCA in 2023 in collaboration with the Nitrosamine International Technical Working Group.

“The CPCA considers the relative activating and deactivating effects of multiple features in nitrosamines and uses this information collectively to generate a prediction of carcinogenic potency and recommend an AI limit,” the report says. “The CPCA is easy to use and can be rapidly applied without the need for specialized software. The CPCA draws on a larger body of carcinogenicity data than determining an AI limit based on a single comparator and it allows an AI to be determined when no safety data for the impurity are available.”

Further development of the CPCA is expected, FDA says, as new experimental studies help identify additional features and properties that may be appropriate to include.