Tagged with FDA

Global With clinical trials having become extremely expensive to conduct, industry buzz around the potential of data and artificial intelligence (AI) to allay these costs has grown. However, experts are split as to the true potential of digital tools to reduce clinical development outlay and provide better patient outcomes in the…

Japan In April 2019, Yasuhiro Fujiwara was appointed as the new chief executive of Japan’s drug regulator and one of the world’s foremost regulatory bodies, the Pharmaceuticals and Medical Devices Agency (PMDA). Upon appointment, Fujiwara coined the “Four Fs” strategy, urging PMDA employees to have a “patient first,” “access first,” “safety…

Global To celebrate International Women’s Day 2020, PharmaBoardroom brings you insights from some of the most inspirational female industry leaders we have had the privilege of talking to over the past 12 months.   Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER), US FDA     Science really can…

USA Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and Research (CDER). Approvals of products such as vaccines and gene therapies by the Center for Biologics Evaluation and Research (CBER) are not included in this drug count. Made with…

USA In an exclusive interview, Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER) at the US Food & Drug Administration (FDA) outlines how the world’s gold-standard agency for regulatory science is adapting to game-changing and often extremely expensive new therapies, why a sizeable impact from data and…

India Below is a selection of the top stories in Indian pharma from recent months, ranging from efforts to counter the coronavirus, to regulatory reform, the spike in USFDA warning letters to Indian pharma manufacturers, promising export markets, and the growth of the Indian domestic market.   Repurposing HIV drugs to…

India Biocon, the first Indian company to have a biosimilar drug approved in the US, is taking another step forward with a new manufacturing facility and an expansion into the Australia and New Zealand markets.   We see ourselves as a company that has great capabilities and is investing big time…

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…