In 2019, the US FDA's Center for Drug Evaluation and Research approved 42 novel drugs, down from 59 drugs approved in 2018. Novartis had four drugs…

Peter Marks, director of the US FDA's Center for Biologics Evaluation and Research, outlines how the organization is attempting to further promote the…

Dr Tares Krassanairawiwong, secretary-general of the Thai FDA shares the recent reforms carried out in the hope of facilitating greater patient access…

In a context where even well-established, multi-billion-dollar domestic companies have received warning letters from the US FDA, quality compliance…

One issue grinding the gears of the Indian pharmaceutical industry over recent years has been quality compliance. With a number of pharma…

Dr. Letitia Robinson, Director of the US FDA India Office, provides insights into the main goals and responsibilities of the FDA in India and…

While drug developers, healthcare practitioners and patients all rejoice at the advent of a golden age of scientific advancement in medicine –…

India leads the way in terms of the sheer volume of US FDA-approved manufacturing plants with over 100, compared to only 28 in China. In…

Murtaza Khorakiwala, managing director of Wockhardt, discusses the company’s vast international expertise in the manufacturing of pharmaceuticals…

As managing director of India’s fifth largest pharmaceutical company, Zydus Cadila’s Sharvil Patel shares his insights on his impressive…

Deloitte predicts that the global market for biosimilars will reach between USD 25 and 35 billion by 2020, driven by some key global biologic drugs…

Newly appointed commissioner of the Food & Drugs Administration (FDA) of the Indian state of Maharashtra, Dr. Pallavi Darade, shares her…