Category Archives: FDA

Shkreli: A supervillain with a dastardly plan? Or a distraction from the real problem?

As the saga of Martin Shkreli continues to unfold in all its obnoxious glory, with every tweet and smirk signifying the former biopharma CEO’s apparent aspirations to a level of sheer jerkiness heretofore unseen on planet Earth, there’s one question…

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Lessons learned from You-Know-Who

Duchesnay Inc.’s 15-minutes of fame for its morning sickness drug arguably turned into a few hours’ worth by time the drugmaker complied with an FDA warning letter demanding a corrective ad to offset the omission of risk information in paid…

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You’ve come a long way, baby, but still a long way to go

Patients have come a long way to get a say in the drug development and approval process. But there’s still some ground to cover if they’re going to move from the passive subject role to a 50-50 partnership that reminds…

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Emerging biosimilar market knows no parallel

It’s not every day that drugmakers get a chance to take on an entirely new market. Biosimilars are offering that opportunity. And hundreds of drugmakers, research institutions and governments are hoping to make the most of it. The result is…

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A little irony here? FDA’s technical difficulties on social media webinar send folks a’Twitter’

For more than five years, the FDA was criticized for failing to provide clear guidance on how drug developers could use social media without running afoul of its marketing restrictions. Last month, the agency finally came through with two crucial…

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Hamburg: Society needs to weigh in

Including the patient voice in the drug approval process could produce a fundamental shift in the risk-benefit equation of a new drug. But first, the FDA has to figure out how to do it, and that may take a broader…

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Rock to the left, hard place to the right: One dilemma of compassionate use

Before its unfortunate drop in quality in its last few seasons, the medical drama House was one of my favorite shows, with its title character, a cranky, possibly drug-addicted doctor solving diagnostic riddles and saving lives with Sherlockian brilliance, and quite…

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Human germline engineering: The mom’s not in the picture

U.S. and British government agencies are moving toward enabling what would be the first clinical trials of what is, in effect, human germline engineering – genetic modifications that would be passed down through the generations. The modifications would not be…

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Patient Experience Still Undervalued in Regulating Drugs

As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The…

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The FDA Should Provisionally Approve Vascepa

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) rocked the biotech industry last week by voting 9 to 2 against approval of Amarin Pharmaceuticals Inc.’s fish-oil derived omega-3 supplement Vascepa in the supplemental indication of mixed dyslipidemia. The drug…

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