Pharmaceutical Industry News
Analysis of regulation, quality, innovation, market and trends in Europe and Latin America.
FDA issues preliminary guidance for medical devices with Artificial Intelligence
First Guidance to Provide Comprehensive Recommendations for Artificial Intelligence in Medical Devices for Developers...
EU Regulation 2021/2282 on Health Technology Assessment Enters into Force
As of January 12, the EU regulation comes into effect to facilitate access to innovative medicines and medical devices, with INFARMED actively...
FDA issues preliminary guidance for medical devices with Artificial Intelligence
First Guidance to Provide Comprehensive Recommendations for Artificial Intelligence in Medical Devices for Developers...
FDA Proposes Draft Guidance to Ensure AI Credibility in Drug and Biologic Submissions
FDA releases comprehensive guidance draft with recommendations on the use of artificial intelligence to support regulatory decisions regarding the safety, efficacy, and...
Anvisa Updates Procedures for Borderline Products
The National Health Surveillance Agency (Anvisa) recently updated its guidelines on the procedures for classifying border products....
Portugal is the second-largest exporter of medicinal cannabis in 2024
Portugal has already exported 18,521 kg of medicinal cannabis, and aims to reach 25 tons by the end of 2024....
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