Month: August 2025

FDA Moves to Real-Time Adverse Event Reporting This is a big step toward modernizing drug safety oversight by the FDA. Starting August 22, 2025, the agency will publish daily updates from the FDA Adverse Event Reporting System (FAERS), instead of quarterly releases.It makes a difference for it leads to: 1. Faster detection of safety signals… Continue reading FDA Moves to Real-Time Adverse Event Reporting

The FDA has announced FDA PreCheck— a program to boost domestic drug (API) manufacturing. The UK Government has unveiled a major regulatory reform aimed at accelerating patient access to innovative therapies by 3–6 months, positioning the UK as a more attractive environment for life sciences innovation and investment. Under a new joint pathway, the MHRA and… Continue reading The FDA has announced FDA PreCheck— a program to boost domestic drug (API) manufacturing.

UK Streamlines Regulatory Pathway to Accelerate Market Access by 3–6 Months. The FDA has announced FDA PreCheck— a program to boost domestic drug (API) manufacturing. The program includes two phases: 1.Facility Readiness Phase – Early FDA input on facility design, quality systems, and operational maturity through a Type V DMF. 2.Application Submission Phase – Enhanced support… Continue reading UK Streamlines Regulatory Pathway to Accelerate Market Access by 3–6 Months.