The Union Health Ministry is in talks with states about extending the deadline for pharmaceutical companies to meet new ...

In order to usher in domestic & global regulatory compliance in pharma sector under the current revised Schedule M regime in India, cGxP Lifeline hosted its first Annual Conference 2025 in Mumbai ...

Digital GMP expectations are increasing, driven by Annex 11 and Annex 22, necessitating robust lifecycle management, data ...

Samsung Biologics acquires Human Genome Sciences from GSK for $280 million, expanding its US manufacturing footprint. The ...

Billions of prescriptions for generic drugs are filled in the U.S. annually. The FDA tests only a few dozen of them every ...

The inspection was conducted from December 15 to December 19, 2025, and concluded with five observations related to procedural requirements. The company said none of the observations are associated ...

For decades, the FDA made it nearly impossible to know which factories were manufacturing your generic medications. ProPublica built a tool to show you. Here’s how we did it.

Vaxxas has received a licence from the Therapeutic Goods Administration to manufacture its needleless vaccine delivery patch for use in clinical trials at its biomedical facility in Brisbane.

The Food Safety and Quality Assurance professional development course provides professionals with a comprehensive understanding of modern food safety and quality assurance programs, regulations and ...

Cell and extracellular vesicle (EV)-based therapies represent a promising frontier in regenerative medicine and immunotherapy. However, their clinical translation is often constrained by the ...