This article explores how digital maturity in process design and parameter management can drive significant time and cost savings, streamline tech transfers and ultimately accelerate patient access to ...

New gene therapy modalities, such as CRISPR guide RNA (single guide ribonucleic acid [sgRNA]) and messenger RNA (mRNA), ...

Cardiovascular diseases (CVDs) are the key factors leading to death and disability worldwide. This severe challenge has prompted the scientific research and ...

Ovarian Cancer Targeted Medication: PARP Inhibitors, Anti-Angiogenic Drugs, Immunotherapy, and More Ovarian cancer is the malignancy with the highest rate of death from tumors of the female ...

During a session in the Rajya Sabha, MP Sushmita Dev raised queries regarding the substandard quality of generic medicines, the implementation of new Good Manufacturing Practices (GMP), and the ...

A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...

Over the past nine years, patients with spinal muscular atrophy have seen the number of FDA-approved treatment options for ...

The European Commission is for the first time is evaluating the European Food Safety Authority's performance, with speciality ...

Ppk stands for Process Performance Index and is used for long-term variability. Overview: What Is Ppk? Ppk is a performance ...

The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...

When I started working at Independent Women, one of my assignments was advancing a first-of-its-kind legislative model to define “sex.” Developed by Independent Women in 2021, the concept was ...

However, as groundbreaking as these therapies are, they also pose unique challenges for the drug development process, particularly regarding quality ... Automated systems can perform repetitive ...