It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified ...

Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into ...

The program aims to aid submissions from external stakeholders and FDA staff. On July 26, 2023, FDA released a guidance document on a program at FDA’s Center for Drug Evaluation and Research (CDER) to ...

Pharmaceutical impurity reference standards are crucial for ensuring the safety and efficacy of medications. Innovations in this field are driving advancements in life sciences research, offering new ...

The U.S. Pharmacopeia (USP), the world's only nongovernmental pharmacopeia, establishes state-of-the-art standards to ensure the quality of medicines, dietary supplements, and other healthcare ...

Drug approvals depend on frameworks invisible to patients but essential to survival. Behind every approved therapy lies a complex compliance and governance infrastructure that determines whether ...

The Standards Organisation of Nigeria (SON) has called on the pharmaceutical manufacturers to strengthen the industry through the development, adoption of standardisation for the nation’s economy ...

The Pharmabiotic Research Institute (PRI), Europe's only regulatory expertise centre for the development of microbiome-based drug products, has announced the publication of a review titled "Live ...

The Armenian pharmaceutical industry has to apply the Good Manufacturing Practice (GMP) standards from 2013. This will enable the country to increase exports not only to the other CIS member countries ...