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Advancing antibiotic development in the age of ‘superbugs’
While antibiotics are necessary and crucial for treating bacterial infections, their misuse over time has contributed to a rather alarming rate of antibiotic resistance, including the development of...
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Cost, value and patient outcomes: The growing need for payer engagement
Editor’s note: This article appears in the April 2015 issue of Global Forum. Click here to view the full publication. Since passage of the Affordable Care Act in 2010, the last several years have seen...
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Breakthrough therapy designation: A primer
Breakthrough therapy designation (BTD) is the newest of four expedited programs developed by the U.S Food and Drug Administration (FDA) to accelerate the development and review of novel therapies that...
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The medical device tax: A primer
Quickly following on the heels of the midterm elections, Senate Majority Leader Mitch McConnell (R-KY) indicated that the medical device tax was a key target for repeal in the 114th Congress. Today,...
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Faster, more efficient innovation through better evidence on real-world...
Many proposals to accelerate and improve medical product innovation and regulation focus on reforming the product development and regulatory review processes that occur before drugs and devices get to...
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Why legislative proposals to improve drug and device development must look...
Legislative proposals to accelerate and improve the development of innovative drugs and medical devices generally focus on reforming the clinical development and regulatory review processes that occur...
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Event recap: Lessons learned from two years of breakthrough therapy designation
The breakthrough therapy designation (BTD) program was initiated by the U.S. Food and Drug Administration (FDA) in 2012 to expedite the development of treatments for serious or life-threatening illness...
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Incorporating continuing education into single-drug REMS: Exploring the...
The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product...
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Vaccines and nervous parents: Why spacing out the vaccine schedule is not the...
The ongoing national debate about vaccines and their alleged connection to autism flares up every so often, much as it did a few weeks ago following the latest GOP debate. Fear over the side effects of...
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