Ethanol - an important Active Ingredient for Infection Prevention?
WHO, KRINKO and RKI are concerned with the pending biocide approval and indispensability of ethanol as a component of infection prevention and healthcare. They have published a corresponding statement.
FDA issues revised draft Guidances for Track and Trace
The Drug Supply Chain Security Act (DSCSA) distribution security requirements will come into effect in November next year. To help trading partners comply with the DSCSA, the U.S. FDA recently issued revised versions of two previously published draft guidances.
FDA Warning Letters for CBD Products used in Farm Animals
The FDA posted several Warning Letters to companies illegally selling cannabidiol products intended for use in food-producing animals due to safety concerns. The agency is taking these steps to protect animals and the safety of the food supply chain.
Serialization - Version 20 of the Q&As on Safety Features
The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Is it allowed to verify the authenticity of the UI when the product is not in physical possession?
The recently published EMA Annual Report 2021 gives a good overview of the Agency's activities in the first chapter, such as actions related to the management of the COVID 19 pandemic, work related to the scientific evaluation of medicinal products and their monitoring.
Benefit-Risk Assessment for Product Quality Evaluation
Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.
With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.
In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.