By Tim Horn In response to growing public concern with health risks posed by approved drugs, a 2006 landmark report by the Institute of Medicine (IOM) argued that the U.S. Food and Drug Administration (FDA) lacks the unambiguous authority necessary…
Federal legislation promises a substantial increase in NIH funding—at the expense of a significantly weakened FDA By Kenyon Farrow For more than a year, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) of the House Energy and Commerce Committee hosted…
Can regulatory incentives promote responsible TB drug development? By Lindsay McKenna and Erica Lessem There are woefully few drugs in development with the potential to improve the safety and effectiveness of tuberculosis (TB) treatment. Indeed, the market-driven approach to drug…
Supportive regulatory guidance for cure research requires a clear understanding of all possible outcomes, including remission By Richard Jefferys The term remission is increasingly being invoked in the context of cure research and, by extension, is an issue for regulatory…
Worldwide inefficiencies in drug approval processes are proving disastrous for people living with TB and other diseases By Erica Lessem Access to safe and effective tuberculosis (TB) medicines depends greatly on efficient and stringent regulatory review, without which improved health…
Regulatory filing and review delays keep Truvada as pre-exposure prophylaxis out of reach of those who need it most By Scott Morgan Pre-exposure prophylaxis (PrEP) is the use of antiretroviral medication to prevent HIV acquisition. The U.S. Food and Drug…
In Defense of Stringency: In response to growing public concern with health risks posed by approved drugs, a 2006 landmark report by the Institute of Medicine (IOM) argued that the U.S. Food and Drug Administration (FDA) lacks the unambiguous authority necessary to ensure the safety and efficacy of the country’s medicinal products.
As the Bill & Melinda Gates Foundation realigns its TB vaccine strategy to focus on early-stage candidate development, equitable access priorities must also be established before large-scale trials are conducted By Mike Frick The Bill & Melinda Gates Foundation has…
Hepatitis C is now curable. Now all we need is surveillance to monitor it, global funding to fight it, and targets set to address it By Tracy Swan The first global targets for eliminating hepatitis C virus (HCV) will be…
Optimism is not without merit, but the science remains incredibly fragile By Richard Jefferys We’re pretty optimistic in this 15-year period we will get those two new tools. —Bill Gates, World Economic Forum, January 23, 2015 Earlier this year, Bill…