News

In a news dated 24 September 2025, we referred to an FDA guideline on 'remote oversight tools'. The exact title is 'Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications'. It presents alternatives to on-site inspections in the context of applying for approval.

More

In mid-September 2025, the updated so called Classification Guideline was published on the European Union (EU) website and will therefore be mandatory from mid-January 2026 (15 January 2026). It was revised and expanded as part of the update to the Variations Regulation.

More

The FDA has published a final Guidance Document on the possible use of alternative methods in the preparation of inspections or even in place of inspections for pending marketing authorisation applications.

More

Again, four Warning Letters from the FDA were published, criticising not only inadequate Quality Oversight but also the Root Cause Analysis and CAPAs implemented. One company in India and three in the USA were affected.

More

In July and September 2025, the Questions & Answers documents relating to centralised authorisation procedures were updated again and published on the European Medicines Agency (EMA) website.

More

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.

More

The FDA Office of Pharmaceutical Quality has published its fiscal year 2024 Report on the State of Pharmaceutical Quality, including a summary on Warning Letters, Import Alerts and Recalls.

More

During an inspection, the FDA identified significant deficiencies in microbiological safety, as well as in the handling of deviations and maintenance, at a Swedish manufacturer. As the responses and measures taken by the company concerned were deemed insufficient, the FDA has now issued a Warning Letter.

More

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.

More

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.

More
x
Search