Phasing out of Animal Testing for Next Generation Drugs New medicines need not be tested in animals to receive US Food and Drug Administration (FDA) approval. The Act 2.0 passed by Congress has created options for pharmaceutical companies to use novel technologies, and Artificial Intelligence as alternatives to animal testing. By signing this into law in December 2022, President Biden responded to the emergence Read more
Clinical Research Focus. 13th Edition February Marks the Beginning of Mandatory Use of CTIS for EMA’s New Clinical Trial Applications The use of the Clinical Trials Information System (CTIS) has become mandatory for new clinical trial applications and now serves as the single-entry point for submission and regulatory assessment. The new regulation has come into effect on January 31, 2023. EMA informed its Management Read more
Clinical Research Focus. 12th Edition Cromos Pharma’s Guide to the EU Legal Representation Requirements Any biopharmaceutical company that plans to conduct clinical trials in the EU and doesn’t have a registered office in the European Economic Area (EEA), needs to use the services of a Legal Representative. First established in 2001, this provision aims to ensure that the EU offers Read more
Clinical Research Focus. 11th Edition Serbia – The Land of Opportunity in Clinical Research Over the years, Serbia has become a highly reputable location to conduct clinical research. The country has actively strived towards developing a robust healthcare system and adopted full GCP compliance. There are 322 clinical trials currently occurring inside Serbia’s borders. Increasing number of biotechnology and pharmaceutical Read more
