Tagged with FDA

USA 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 approved, the highest number from any single pharma company. 16 of the 42, or 38 per cent, received orphan drug designation. This listing does…

USA Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research, outlines how the organization is attempting to further promote the advancement of cutting edge cell and gene therapies in the US and beyond.   To keep pace with the remarkable and continuing growth of gene therapy, FDA’s…

Thailand Dr Tares Krassanairawiwong, secretary-general of the Thai FDA shares the recent reforms carried out in the hope of facilitating greater patient access to both domestic and internationally-produced treatments. Dr Krassanairawiwong also highlights the institution’s current priorities, including medical cannabis, positioning Thailand as a clinical trials hub, and further developing the…

India In a context where even well-established, multi-billion-dollar domestic companies have received warning letters from the US FDA, quality compliance has clearly become strategically important across all layers of Indian organizations, including formulation and API companies as well as both B2B and B2C players.   My approach is extremely simple: quality…

India One issue grinding the gears of the Indian pharmaceutical industry over recent years has been quality compliance. With a number of pharma manufacturers the recipients of warning letters from the US FDA, increased regulatory scrutiny has caused some consternation, but also progress in quality standards across the board. “I see…

India Dr. Letitia Robinson, Director of the US FDA India Office, provides insights into the main goals and responsibilities of the FDA in India and documents the US FDA’s collaboration efforts with its Indian regulatory counterparts. Could you introduce to our international readers the US FDA’s Office of International Programs and…

Pharma While drug developers, healthcare practitioners and patients all rejoice at the advent of a golden age of scientific advancement in medicine – symbolized by recent radical breakthroughs in all manners of domains from stem cells and CAR-T generation immunotherapy to gene tech and 3D bio-printing – it is clear that…

Pharma 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 terms of the global competitiveness of Brazil, Russia, India, China and South Africa (BRICS), China remained out in front between 2012 and 2015, with India…

India Murtaza Khorakiwala, managing director of Wockhardt, discusses the company’s vast international expertise in the manufacturing of pharmaceuticals and biopharmaceutical formulations in their 12 US FDA, UK MHRA and EMA compliant manufacturing facilities in India, as well as the out-licensing of its products into other regions to capture and penetrate new…

India As managing director of India’s fifth largest pharmaceutical company, Zydus Cadila’s Sharvil Patel shares his insights on his impressive internationalization strategy with a special focus on the US where Zydus recently received permission to conduct Phase II clinical studies of Lipaglyn, the first drug to treat patients with nonalcoholic steatohepatitis…

India 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 facing loss of exclusivity in the next few years and an increasing global focus on improving healthcare access and the cost of care. Against this…

India Newly appointed commissioner of the Food & Drugs Administration (FDA) of the Indian state of Maharashtra, Dr. Pallavi Darade, shares her objectives to further consolidate the FDA’s positioning as a transparent, efficient and trusted regulatory institution by involving the industry in any consultation and make them an integral part of…