FDA

Technology transfer, or the practice of transferring scientific findings from one organization, most notably universities, to another for further development, plays a pivotal role in the R&D ecosystem. It is the bridge that ensures knowledge cultivated through academic research reaches patients and other beneficiaries, and it is a critically important means of financing further science and technology at academic institutions in the U.S. and around the world. The Association of University Technology Managers (AUTM), a nonprofit organization with an international membership of more than 3,000 technology managers and business executives, has developed a project that not only highlights the...
Scientific research is advancing the frontiers of knowledge with discoveries that will ultimately lead to the eradication of life-threatening conditions. Translating discoveries into safe and effective treatments for patients, however, requires robust investments, collaboration and the support of a modernized regulatory system. “When our laws don’t keep pace with innovation, we all lose,” said Representative Fred Upton (R-MI-06), chair of the House Energy and Commerce Committee. Rep. Upton and Rep. Diana DeGette (D-CO-01) are spearheading the 21 st Century Cures Act which aims to accelerate the pace of medical innovation from discovery, development to delivery. During the upcoming BIO...
The serendipitous discovery of penicillin by Alexander Fleming in 1928 transformed the course of modern medicine. Penicillin, followed by a series of other antibiotics, seemed to promise a world free of infectious diseases that once killed millions of people worldwide. Medical breakthroughs such as organ transplants and chemotherapy would not have been possible without the development of antimicrobials. Fleming warned, however, that microbes have the ability to, and inevitably will, develop resistance to antibiotics. It did not take long to prove him right, with drug-resistant strains appearing just within years after the introduction of penicillin, as was the case for many subsequent...
Dear Research Advocate, I am pleased to repeat myself when I report that it’s been another science-heavy week on Capitol Hill...and most, but not all, of the news is good. This morning, the Energy and Commerce Committee passed (51-0, a tremendous bipartisan victory) the 21st Century Cures Act with new mandatory funding for FDA, and with the NIH Innovation fund intact...and both are paid for! Representatives Upton (R-MI-06) and DeGette (D-CO-01) kept their word and managed, in an extraordinarily tight fiscal environment, to negotiate viable supplemental funding for federal agencies pivotal to medical progress. I am not saying the bill is perfect, nor arguing that stakeholders should support...
Dear Research Advocate: Today the Energy and Commerce Health Subcommittee considered the 21st Century Cures Act . This bill, in the making for over a year, is now officially 'out of the starting gate' and under consideration by our elected representatives. After a unanimous vote for approval in the subcommittee, a full committee markup is planned for next week. In advance of the subcommittee's consideration, Research!America organized a group sign-on letter expressing support for the NIH Innovation Fund included in the bill. Our thanks to the 187 organizations within and outside of the Research!America alliance who participated! As the bill moves through the legislative process in the House...
Today, Research!America urged the 114th Congress to take action on five science priorities in the first 100 days of the legislative session in order to elevate research and innovation on the nation’s agenda: Advance the 21st Century Cures Initiative. Spearheaded by Representatives Fred Upton (R-Mich.) and Diana DeGette (D-Colo.),the initiative is a promising step in the right direction, focusing on speeding medical progress from bench-to-bedside by integrating patient perspectives into the regulatory process, modernizing clinical trials, and reducing red tape, among other things. Repeal the medical device tax. A provision in the Affordable Care Act, efforts to repeal the medical device tax...
Dear Research Advocate: As America rings in the New Year, many of us will be reflecting on the past and making resolutions for the future. To get a feel for the numerous ways in which NIH, CDC, AHRQ, NSF and FDA contributed to the well-being of Americans and others throughout the world in 2014, click here . I hope lawmakers are taking time now to establish New Year’€™s resolutions and set priorities for the new Congress, which convenes one week from today. My biggest wish for the new Congress? Pragmatism over politics. If pragmatism rules, the next Congress will shake off the stultifying complacency that is weighing our nation down and act to reignite U.S. innovation. More here . One reason...
Dear Research Advocate: So much is troubling our nation – evidenced in protests of recent grand jury decisions and the controversy over release of the Senate’s report on the CIA – that most people probably haven’t noticed or cared that the Congress is delaying and may even abort action on the long overdue funding of the federal fiscal year that began on Oct. 1. People have grown tired of Congress missing self-imposed deadlines, only to say they can only act in the face of those deadlines, and now they are talking of doing it again. And thus we are lulled into thinking it doesn’t matter what the Congress does. But that would be wrong: priority-setting by the Congress plays a major role in...
The tiny increases included in the “Cromnibus” bill for the National Institutes of Health (NIH) and our nation’s other health research agencies are just that. The underwhelming support for the NIH, the Centers for Disease Control and Prevention, the National Science Foundation and the Food and Drug Administration following years of stagnant funding and budget cuts begs the question – how low can we go, given health threats the likes of which stand to bankrupt the nation? And the decision to flat-fund the Agency for Healthcare Research and Quality does not provide what it takes to reduce the much-complained of inefficiencies in our health care system. The pain and economic drain of one...
Dear Research Advocate: As I write, most members of Congress are on the way home for August recess. As anticipated, no further action has been taken on the appropriations front ’€“ or much else, for that matter. In terms of issues we care about: no movement on tax reform, which means no much-needed enhancement of the research and development tax credit; no repeal of the medical device tax; and no final passage of Fiscal Year 2015 appropriations bills. In upcoming letters I will talk in more detail about Capitol Hill-focused advocacy strategies through the election and beyond. In the absence of legislative action, some attention ’€“ in a bipartisan manner ’€“ is being given to research for...

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