A new paper in the latest issue of Health Affairs is worth a look. “Drugs Cleared Through The FDA’s Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process“
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John Zhang, a New York fertility doctor, wanted to push the boundaries of science and fertility by giving women at risk of passing on serious genetic conditions a chance at healthy kids through an IVF technique that uses the DNA of three people
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The US FDA currently forbids any use outside of a research setting. But recent history has shown that people who want access to such techniques “can find people willing to perform them in venues where they’re able to do so,” said Jeffrey Kahn, who directs Johns Hopkins University’s Berman Institute of Bioethics. “It will happen whether we discuss it or not, and we need to talk about these things before they happen, That’s now.”
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Stacey Lee, an assistant professor at JHU’s Carey Business School, suggests a more transparent process for patients
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The agency is proposing new rules that could save millions of lives
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The approval of gene therapy for leukemia, expected in the next few months, will open the door to a radically new class of cancer treatments
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The FDA Is An Integral Part Of Compassionate UseJuly 6, 2017 |
If you were dying, surely you would grasp at any chance medicine might offer you. Recently, there has been a lot of effort at the state and federal levels to try to increase patient access to experimental drugs. The approach has been to cut the FDA out of what is known as “compassionate use”
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Pediatricians and public health researchers know they have to be on the lookout for lead exposure from paint chips and contaminated drinking water. A new report suggests food — particularly baby food — could be a problem, too
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