Tagged with FDA

Saudi Arabia In a recent conversation with PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA) outlined the organisation’s strategic priorities. As part of the Authority’s 2018-2022 strategic plan, it has set out a number of goals, ranging from setting clearer objectives to strengthening its capabilities,…

Saudi Arabia Speaking exclusively to PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA), outlines the SFDA’s key priorities under its current strategic plan. He also touches on why domestic pharma and medtech manufacturing is important to the SFDA, pricing issues for innovative new therapies, and…

USA In 2020, the US FDA’s Center for Drug Evaluation & Research (CDER) approved 53 novel drugs, up from 48 in 2019, across a range of therapeutic areas, including the first treatments for COVID-19 patients.   The FDA’s Center for Biologics Evaluation & Research (CBER) is charged with approving new biologic…

USA Hours after President Biden was inaugurated on Tuesday 19th January 2021, Dr Janet Woodcock was named as acting commissioner for the Food and Drugs Administration (FDA). “The FDA’s public health work is more critical than ever as we continue to fight this global pandemic… The American people can be certain…

USA A Tale of Two Americas The US stands as the biopharma innovation champion of the world, a global leader on nearly all R&D indices related to investment and innovation. It also holds a tremendous amount of clout, representing half the world’s healthcare market, and the US healthcare industry itself is…

Global 2020 was a challenging year globally, but one in which the importance of the healthcare and life sciences sector was underlined like never before. Despite lockdowns and travel restrictions, PharmaBoardroom still managed to talk to key industry stakeholders from across the world helping shape the future of global health. Featured…

USA Rare disease – defined in the US as a disease with a maximum patient population of 200,000 – is perhaps the most salient issue at the nexus of innovation, access, and affordability in the country.   As FDA CDER director Dr Janet Woodcock indicates, “rare diseases have been rising as…

USA In his latest piece on Alzheimer’s Disease (AD) drug Aducanumab’s winding journey to market, Dr Neil Cashman looks forward to the US FDA Advisory Committee’s meeting on November 6 2020, what it means for that Aducanumab, and the impact on next-generation AD treatments.   November 6 could prove to be…

USA Dr Peter Marks MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), highlights the Center’s contributions related to the regulatory science behind vaccine development, including vaccines to prevent COVID-19; the Center’s efforts to facilitate the advancement of the field…

USA In a recent virtual town hall meeting hosted by BIO, two key leaders from the US FDA laid out how their organisation has adjusted in the wake of the COVID-19 crisis, at what stage of development diagnostics and therapeutics for the virus are, and the pandemic’s long-term effects – both…

USA So far in 2020 PharmaBoardroom has conducted interviews with several key stakeholders in US healthcare. We have heard from leaders the US FDA, as well as representatives of patient groups, health insurance providers, and firms operating in the US on what they consider the most pressing issues facing US healthcare.…

India A recent IQVIA report highlights the increasing importance of Indian firms to the USA’s burgeoning generic pharmaceuticals market.   Now accounting for over 90 percent of all prescriptions dispensed in the USA, generic drugs play a vital role within US healthcare and have come a long way since their use…