Tagged with FDA

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…

USA In 2016, rumours of a weakening FDA followed a disappointing 16 new drugs approved for the full year. However, since the beginning of 2017 the FDA has approved 26 drugs; double the amount of the mid-year average since 2007. “The eight oncology treatments approved by the FDA this year represent…

USA Speaking exclusively to PharmaBoardroom at the 2017 BIO Convention in San Diego, former FDA Commissioner Andrew von Eschenbach lifts the lid on the ‘FDA Beyond Our Borders’ project that he initiated. Dr. von Eschenbach, you were the FDA Commissioner for three years, from 2006 to 2009. What do you see…

life sciences John Taboas is the president of Biopharma Consulting Services (BCS), a leader in visual inspection and other validation and engineering services. Here he tells PharmaBoardroom how the company is working to position Puerto Rico as a hub for subject matter experts in visual inspection, with a new training facility and inspection…

marketing Ivelisse Casillas, founder of PharMaCon, Inc. talks about the challenges of marketing and advertising pharmaceuticals products in Puerto Rico. She founded the company in 2000 to provide advertising, legal and medical expertise to the sector. What are the main advertising challenges that your clients face with which you can help them? The biggest…

government PharmaBoardroom met the Secretary General of the Thai FDA and the Senior Expert on Pharmaceutical Standards at the FDA. They explained the FDA’s role in Thailand’s pharma market, what the organization is doing for Thai copyright rights, how it is promoting international investment and integration within the ASEAN Economic Community. Please introduce…