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
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 businesses.
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
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 FDA on or before April 1, 2012.