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The comment periods for the USP chapters 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' closed at the end of 2024. In the meantime, both chapters have been finalised and are now available for viewing. Both documents are set to become officially valid in February 2026.
As part of the revision and reorganisation of the USP chapters on biological assays, the USP has now published the draft revision of chapter <111> ‘Design and Analysis of Biological Assays’. The revision was also necessitated by the contents of the new chapter <1034>.
WHO: With the publication of new guidelines, another relevant organisation is now emphasising the importance of the 3R principle in the quality control and quality assurance of biopharmaceutical products. This means that efforts in Europe and, for some time now, in the USA are now also moving in the same direction globally.
In a Warning Letter sent to an american manufacturer in June, the FDA documents a whole list of deficiencies, ranging from a lack of testing of the components used to incorrect or faulty approvals, claims, and listings.
NIH in line with the FDA: the topic of 3Rs, i.e., replacement, reduction, and refinement of animal testing, remains a focus. In the future, the NIH will no longer fund research projects that rely exclusively on animal testing.
On 12 August 2025, the U.S. Food and Drug Administration (FDA) published a Warning Letter to a U.S.-based manufacturer of over-the-counter (OTC) drug products. During an inspection, the investigator observed several specific CGMP violations.
In the recently published USP–NF 2026 Issue 1 Commentary (dated 25 July 2025), USP summarized stakeholder feedback and editorial decisions concerning General Chapter <202> Identification of Fixed Oils by Thin-Layer Chromatography.
At the end of July 2025, the report 'Nitrosamine impurities in human medicines - The response of the European Medicines Regulatory Network' was published on the EMA website.
Im Rahmen der Überarbeitung bzw. Neuaufstellung der USP-Kapitel zu biologischen Assays hat die USP jetzt den Überarbeitungsentwurf des Kapitels <111> "Design and Analysis of biological Assays" veröffentlicht. Die Revision wurde auch durch die Inhalte des neuen Kapitels <1034> notwendig.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an Indian contract testing laboratory. Investigations of out-of-specification (OOS) results lacked adequate scientific rationale, and new test results were used to invalidate prior OOS findings without sufficient justification. Furthermore, FDA investigators discovered torn and discarded original CGMP documents in the facility's waste disposal area, and electronic data had been improperly altered or deleted.
