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TAGline 2015


TAGline Fall 2015: In Defense of Stringency

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. The IOM emphatically recommended that Congress enact any legislation necessary to buttress the agency’s enforcement powers so that it may apply the strengths of the pre-approval process, including stringent data review, to postapproval monitoring and regulation.

The 21st Century Cures Act’s “Pathway to Crisis” in Drug Safety
Federal legislation promises a substantial increase in NIH funding—at the expense of a significantly weakened FDA

The FDA’s Concession Conundrum
Can regulatory incentives promote responsible TB drug development?

The Challenge of Defining HIV Remission
Supportive regulatory guidance for cure research requires a clear understanding of all possible outcomes, including remission

Improving Regulatory Systems to Address Global TB Drug Access Failures
Worldwide inefficiencies in drug approval processes are proving disastrous for people living with TB and other diseases

PrEP: The Pathway to Global Access
Regulatory filing and review delays keep Truvada as pre-exposure prophylaxis out of reach of those who need it most

TAGline Spring 2015: On Targets and Timelines

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.

Ending the HIV Epidemic (ETE) in New York State
Not only is it the right thing to do for the health of New Yorkers, but a new analysis demonstrates that it is also cost-effective.

Toward an Ambitious National HIV/AIDS Strategy
We won’t end HIV as an epidemic with anemic goals, delayed surveillance data, feeble support of state policies and resource needs, and an inadequate implementation science agenda.

An HIV Cure and a Vaccine within the Next 15 Years?
Optimism is not without merit, but the science remains incredibly fragile.
By Richard Jefferys

C U L8ter: Hepatitis C Eradication
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.

TB R&D’s Shift to the Left
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.