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

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 ...

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 ...

Health officials clarified that drugs declared NSQ are flagged based on laboratory analysis and regulatory review, and necessary action is initiated against the manufacturers and distributors as ...

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 ...

The central element of these amendments to the New Drugs and Clinical Trials Rules, 2019, is replacing the mandatory licence requirement for non-commercial manufacture of drugs with a prior-intimation ...

In a monthly drug alert issued by the Central Drugs Standard Control Organisation, central drug laboratories found 74 samples manufactured by various firms to be NSQ (not of standard quality), while s ...