Medical regulatory authorities fulfill an essential role by evaluating research and marketing applications for new products. They approve or reject applications based on data indicating safety, efficacy, and quality, gathered from scientifically controlled methods of data collection.
Worldwide funding for tuberculosis (TB) research fell $1.3 billion short of global targets in 2014, according to a report released today by Treatment Action Group (TAG). Total funding of US$674,036,492 in 2014 amounted to barely one-third of the US$2 billion experts estimate the world must spend on TB research and development (R&D) each year to eliminate TB. Alarmingly, funding for TB drug research fell by US$25 million compared with 2013. Overall, funding for TB R&D fell by US$12 million.
Working in tuberculosis (TB) research has long meant laboring with too little and waiting for what comes too late. In recent years, an emergent optimism has crept into TB research, but too often the individuals and institutions that comprise the TB research field find their good ideas and energy put on hold by insufficient funding.
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…
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…
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.
Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.
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…
By Tim Horn With growing recognition that science and discovery have forged the tools necessary to effectively diagnose, treat, and, indeed, eliminate three of the world’s most lethal infectious diseases—HIV/AIDS, tuberculosis, and hepatitis C—there is a need for greater mobilization…
On Targets and Timelines: With growing recognition that science and discovery have forged the tools necessary to effectively diagnose, treat, and, indeed, eliminate three of the world’s most lethal infectious diseases—HIV/AIDS, tuberculosis, and hepatitis C—there is a need for greater mobilization and strengthened accountability among all stakeholders.