Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004
Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004: Article 57(2) of Regulation (EC) No…
Read more →Electronic submission of medicinal product information by marketing-authorisation holders
Electronic submission of medicinal product information by marketing-authorisation holders In the dynamic landscape of pharmaceutical regulation, the European Union (EU) stands at the forefront of ensuring…
Read more →FDA Expands Actions Against Problematic Plastic Syringes from China
FDA Expands Actions Against Problematic Plastic Syringes from China In a recent update, the U.S. Food and Drug Administration (FDA) has announced expanded measures…
Read more →Ensuring Safety and Effectiveness in Stress Urinary Incontinence Treatment: FDA Guidelines and Recommendations
Ensuring Safety and Effectiveness in Stress Urinary Incontinence Treatment: FDA Guidelines and Recommendations Stress Urinary Incontinence (SUI) affects millions of women worldwide, impacting their…
Read more →FDA Approves Consent Decree Addressing Philips Respironics CPAP and BiPAP Recall
The U.S. District Court for the Western District of Pennsylvania has approved a consent decree of permanent injunction against Philips Respironics and associated entities,…
Read more →FDA Approves Zevtera for Serious Bacterial Infections!
FDA Approves Zevtera for Serious Bacterial Infections! Great news on the healthcare front! The U.S. Food and Drug Administration has just given the green…
Read more →