Antibody drugs such as monoclonal antibodies (mAb), bispecific antibodies, antibody-drug conjugates (ADCs), and nanobodies garnered increased interest in research and development circles. Sino ...

Rising recalls, tighter FDA enforcement, global supply chain dependencies, and rapid technology shifts are reshaping pharmaceutical quality and compliance—forcing manufacturers to rethink oversight, ...

ADCs combine antibodies with drug payloads for targeted therapy, but complex manufacturing requires monitoring CQAs across multiple entities.

Quality control errors during pharmaceutical manufacturing are unfortunately common occurrences. The majority (around 50%) of employees that work in pharmaceutical manufacturing tend to have duties ...

Recent articles have prompted questions about the quality of the nation's drug supply. Michael Kopcha, PhD, a registered pharmacist and the director of the Office of Pharmaceutical Quality at the FDA, ...

A year after the FDA found shredded quality documents at an Intas Pharmaceuticals drug manufacturing facility in India, Intas’ parent company Accord Healthcare resumed making cisplatin, which has been ...

America is facing a growing crisis in its medical system — not from a lack of talent or innovation, but from a breakdown in the control, safety and supply of essential medicines. Our growing reliance ...

Investigation raises concerns about lack of FDA quality testing for generic drugs By some estimates, about 90% of prescriptions in the U.S. are filled with generic drugs. The Food and Drug ...

As many as 167 drug samples were flagged as “not of standard quality” (NSQ) across the country in December 2025, the Union health ministry said. According to a monthly drug alert issued by the Central ...