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.
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 determines that a REMS is necessary to ensure the benefits of a drug or biological product outweigh its risks.
MHRA Launches New Monthly Safety Roundup Bulletin and Redesigned Safety Alerts
The MHRA has introduced a new monthly safety bulletin, the MHRA Safety Roundup, as part of its three-year strategy to enhance safety communications. This initiative aims to make information about medicines and medical devices clearer and more accessible for healthcare professionals.