Category Archives: FDA

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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It’s How You Look at the Vial

What’s in a biosimilar name? That depends on whether the vial is half empty or half full. Seeing it as half full, many generic makers focus on the similarities between a follow-on and its reference biologic. Because of those similarities,…

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Oh, Give it Iressa! Nope: ‘Bad Pharma’ Firms Need to Tell More

So urgently did I think I wanted to read Ben Goldacre’s Bad Pharma, that I ordered it from Amazon’s UK site last November, unwilling to wait for U.S. publication – which happened just as I reached the end, polishing off…

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Patients Want More than Check-the-Box Experience

Patients getting their four minutes to say how an experimental drug changed their life or gave them hope have become a routine part of nearly every FDA advisory committee meeting – as routine as the call to order or the…

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Statistical Tinkering in Device Regulation a Disservice to Patients

Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of…

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