Sempre na vanguarda da melhor formação técnica dos profissionais da área Pharma , MedTech e Suplementos Alimentares
PRÓXIMAS FORMAÇÕES
ÚLTIMAS NOTICIAS
FDA CDER – 2025 New Drug Therapy Approvals: key takeaways
The FDA’s Center for Drug Evaluation and Research (CDER) has released its 15th annual New Drug Therapy Approvals report, offering a useful snapshot of the pace and direction of drug development in 2025. In 2025, CDER approved 46 new drugs never before approved or...
The MDSAP Audit Approach (MDSAP AU P0002.010) was just revised
Medical device/medtech regulatory updates this week: The MDSAP Audit Approach (MDSAP AU P0002.010) A few suggested next steps if you're impacted here: 1/ Audit your audit program. Your internal audit procedures and checklists likely reference QSR language and clause...
FDA Clinical Decision Support Software
This document supersedes “Clinical Decision Support Software” issued on January 6, 2026. The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic...
FDA GUIDANCE : Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
The U.S. Food and Drug Administration (FDA) has published “Cybersecurity in Medical Devices: Quality Management System (QMS) Considerations and Content of Premarket Submissions” updated guidance issued 3 February 2026. This guidance replaces the 2025 edition and...
Comprometidos com a qualidade e a inovação.
