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From Discovery to Marketplace: A New Program to Accelerate the Drug...
Today, I tuned into a press conference hosted by the National Institutes of Health with Health and Human Services Secretary Kathleen Sebelius, announcing a new collaborative program to accelerate the...
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PDUFA: The Cliffs Notes
There has been a lot of buzz lately about Congress’ reauthorization of the Prescription Drug User Fee Act, affectionately known as PDUFA (pronounced: pah-du-fa) inside the beltway and in the halls of...
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Pre-Competitive = Pro-Patient?
I attended a BIO 2012 “super session” this afternoon moderated by my friend Margaret Anderson, executive director of Washington, DC-based Faster Cures, a leading advocacy group to “improve the medical...
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PDUFA: Rounding Third, Headed Home
President Obama got in a little hot water earlier this week when he brought up the Boston Red Sox trade of Kevin Youkilis to the Chicago White Sox while hosting a Boston fundraiser. It wasn’t that...
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Pharma Regulatory Issue? It’s Time for a New Plan
The communications landscape in pharma and health care has become increasingly more crowded over the past three to five years. With social media, blogs and other online content as well as traditional...
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A Path to Relieve the Pain – FDA’s Draft Guidance for Abuse-Deterrent Opioids...
Over the past few weeks, FDA has been applauded by many for the efficiency and timeliness of 2012 drug approvals, along with several initiatives, such as the “Breakthrough Therapy” designation...
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We personalize our wardrobes, iPhones and homes. Why not our medicine too?
Earlier this week the Personalized Medicine Coalition (PMC) released “Pathways for Oversight of Diagnostics,” a discussion of regulation surrounding personalized medications. Spectrum is a proud...
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FDA Advisory Committee Meeting, Through the Eyes of a German Health Care...
Hallo! Allow me to first introduce myself. My name is Nicola, and I work at fischerAppelt, Spectrum’s partner PR agency in Germany. Currently, I’m in Washington as part of GLOBALHealthPR’s ongoing...
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FDA’s Breakthrough Therapy Designation: Capitalize with Communication
The U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy designation, first approved in July 2012, provides ways to speed the development and review of drugs where preliminary clinical...
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FDA serves notice with trans-fats ruling
Last week, the U.S. Food and Drug Administration announced the potential elimination of most trans fat from the nation’s food supply. This preliminary ruling identified partially hydrogenated oils –...
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10 things you should know about FDA’s new social media guidance
Yesterday the Food and Drug Administration (FDA) released draft guidance for digital media. The document was short and to the point, and focused more on content created by the general public than...
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