Announcements

Announcements

Gavi [to 18 March 2017]
http://www.gavi.org/library/news/press-releases/
15 March 2017
Cholera vaccination campaign begins in Somalia
Mass vaccination campaign will target over 450,000 people to halt cholera outbreak.
[See Emergencies above for more detail]

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Global Fund [to 18 March 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
15 March 2017
Global Fund Receives Top Marks in Performance Review
GENEVA – The Global Fund is an effective multilateral organization that provides strong global leadership for the response to HIV, TB and malaria, a group of leading donor countries said in a review that gave the Global Fund top marks in performance.
The evaluation by the Multilateral Organisation Performance Assessment Network (MOPAN), which monitors the performance of multilateral organizations, gave the Global Fund top ratings in organizational architecture, operating model and financial transparency and accountability.
The assessment is here.
Published today, the assessment noted an overall strong performance by the Global Fund in all 12 of its criteria. Key strengths identified point to the Global Fund’s commitment to delivering impact and value for money: clear strategic direction and a proactive approach to innovation and change; results-based budgeting well aligned to strategy within a low operational budget; early identification of operational and financial risks; and vibrant and effective partnerships, particularly those that work with civil society and leverage private sector skills to address operational gaps…

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PATH [to 18 March 2017]
http://www.path.org/news/index.php
Announcement | March 17, 2017
PATH welcomes grant for the collaborative development of solutions for achieving universal health coverage
Award will strengthen and expand the work of the Joint Learning Network for Universal Health Coverage
PATH was awarded $4M to support the Joint Learning Network for Universal Health Coverage (JLN)—a global community of health policymakers and practitioners working to address barriers to achieving universal health coverage in their countries. This investment by the Bill & Melinda Gates Foundation will revitalize and expand the technical work of the network, allowing for continued peer-to-peer learning and co-development of solutions that contribute to the goal of extending effective health insurance coverage to more than 3 billion people…

Announcement | March 16, 2017
PATH Statement on the US President’s Proposed Federal Budget
Proposed Cuts to Global Health Programs and Research Would Stifle Innovation and Make the World—and America—Less Healthy and Less Secure
March 16, 2017—Today the US Administration sent its proposed budget for fiscal year 2018 to Congress. The budget includes extensive cuts to global health and development programs, including approximately a one-third cut to the Department of State and the US Agency for International Development, as well as cuts to vital research programs funded through the National Institutes of Health and the Centers for Disease Control and Prevention. PATH opposes these cuts and believes they will make the world—and America—less healthy and less secure, while also stifling innovation. A statement from PATH’s President and CEO Steve Davis follows:

“Global health and development programs save lives, foster healthier, more prosperous communities, and create a safer, more secure world. The cuts proposed to these programs represent a threat to the health of millions of people around the world—including Americans. At the same time, proposed cuts to scientific research threaten to stifle innovation, which has driven so much of the progress we have seen in the past two decades.

Recent outbreaks of Ebola and Zika made painfully clear that no one is immune to disease outbreaks, and that the world is unprepared for the next threat. It is not a question of if, but when another outbreak will occur, and US government leadership has been instrumental to global efforts to better prevent outbreaks from becoming widespread epidemics. Now is not the time to pull back. Epidemics not only threaten lives, but also cost billions of dollars and disrupt entire economies, when they could be prevented at just a fraction of the cost.

The budget also proposes deep cuts to scientific research, which would not only risk health and safety, but also dampen innovation. Robust research and development efforts are critical to ensure we have tools to tackle the health challenges we face today, and that we are able to quickly respond as new threats emerge. These innovations pay dividends not only in health outcomes, but also as drivers of economic growth. Further, relatively small public-sector investments have the power of catalyzing private-sector engagement, which we have seen at unprecedented levels in recent years. Harnessing the capacity and eagerness of private-sector companies to solve global challenges is essential to tackling complex challenges around the world. These budget cuts will stymie our ability to do so.

Global health and scientific research have historically earned bipartisan support, and we urge Congress to protect these vital programs. There is too much at risk if they do not.”

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FDA [to 18 March 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
:: March 15, 2017 Approval Letter – Zostavax (PDF – 43KB) Posted: 3/17/2017
:: March 15, 2017 Approval Letter – PROQUAD (PDF – 34KB) Posted: 3/17/2017
:: CBER Expanded Access Submission Receipt Reports FY 2016 (October 1, 2015 – September 30, 2016); Updated: 3/7/2017
:: Complete List of Currently Approved NDA and ANDA Application Submissions (PDF – 17KB)
:: Complete List of Currently Approved Premarket Approvals (PMAs) (PDF – 16KB)
Posted: 3/16/2017; Updated as of 3/15/2017
:: Complete List of Substantially Equivalent 510(k) Device Applications (PDF – 409KB)
Posted: 3/16/2017; Updated as of 3/15/2017
:: Complete List of Licensed Products and Establishments Posted: 3/16/2017; Updated as of 2/28/2017