Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance The European Medicines Agency (EMA) invites public feedback on a new draft guideline focused on including pregnant and breastfeeding populations in clinical trials, addressing critical gaps in medicine safety and efficacy data. The consultation is open until… Continue reading Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance
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AI-Powered Pharmacovigilance: The Future of Drug Safety Surveillance
AI-Powered Pharmacovigilance: The Future of Drug Safety Surveillance Artificial Intelligence (AI) refers to the simulation of human intelligence in machines, enabling them to perform tasks such as learning, reasoning, and problem-solving. In healthcare, AI has already shown significant promise in areas like diagnosis, treatment planning, and personalized medicine, transforming patient care delivery.
Overview of FDA Covered Product Authorization (CPA) and the CREATES Act
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Health Canada Validation Criteria 5.3 – Compliance Update Effective May 31, 2025
Health Canada Validation Criteria 5.3 – Compliance Update Effective May 31, 2025 As part of our continued commitment to regulatory compliance and operational excellence, we are notifying our clients, partners, and stakeholders about important updates to Health Canada’s Validation Criteria, version 5.3, which will come into effect on May 31, 2025.
Swissmedic Nitrosamine Risk Assessment Requirements
Swissmedic Nitrosamine Risk Assessment Requirements Swiss agency updated the guidance on nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.
Scheduled Maintenance Notice: ESG NextGen Platform Downtime on May 17, 2025
Scheduled Maintenance Notice: ESG NextGen Platform Downtime on May 17, 2025
The Role of Artificial Intelligence Within the Pharmaceutical Sector
The Role of Artificial Intelligence Within the Pharmaceutical Sector: Businesses in a fast-changing world have always taken advantage of the market’s opportunity to improve their processes, making them smarter, more effective. With the help of Al and machine learning, companies are able to reach their peak efficiency in data analysis that will leave an enormous impact on each other’s… Continue reading The Role of Artificial Intelligence Within the Pharmaceutical Sector
Navigating EMA’s Updated Paediatric Application Procedures: April 2025 Insights
Navigating EMA’s Updated Paediatric Application Procedures: April 2025 Insights On 15 April 2025, the European Medicines Agency (EMA) released an updated version (Rev. 121) of its procedural advice on paediatric applications (EMA/672643/2017). This revision reflects the agency’s commitment to streamlining regulatory processes, enhancing transparency, and supporting innovation in paediatric medicine development across the EU.
Understanding ACA Section 6004: Ensuring Drug Safety and Transparency in Healthcare
Understanding ACA Section 6004: Ensuring Drug Safety and Transparency in Healthcare On March 23, 2010, the Affordable Care Act (ACA) was signed into law. Among other things, the ACA amends the Social Security Act, 42 U.S.C. 1301 et seq., by adding section 6004. This new section requires the submission of certain drug sample information to… Continue reading Understanding ACA Section 6004: Ensuring Drug Safety and Transparency in Healthcare
Risk Evaluation and Mitigation Strategies (REMS) Overview
Risk Evaluation and Mitigation Strategies (REMS) The Food and Drug Administration Amendments Act (FDAAA) of 2007, signed on September 27, 2007, by President George W. Bush, created section 505-1 of the Food, Drug, and Cosmetic Act (FD&C Act) which authorizes FDA to require a Risk Evaluation and Mitigation Strategies (REMS) for certain drugs if FDA… Continue reading Risk Evaluation and Mitigation Strategies (REMS) Overview