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STAT+: After Canada required pharma to pay fees, drug agency recommended coverage more often

STAT

The arm of the agency that handles submissions for medicines began requiring fees in September 2014, while the other unit overseeing cancer drugs took that step in April 2015.

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Opinion: Rising rates of skin cancer: The cost of FDA’s inaction on novel sunscreen products

STAT

authored the Sunscreen Innovation Act , which became law in 2014, Americans are still waiting for newer, more effective sunscreen products due to the Food and Drug Administration’s chronic inaction. A decade after Sen. Jack Reed (D-R.I.)

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDAs GDUFA commitments.

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STAT+: A novel spinal cord stimulator treats paralysis without surgery. FDA will rule on it soon

STAT

After his spinal cord injury in 2014, Sherown Campbell worked hard to regain as much bodily function as he could. Once a dedicated athlete, Campbell had to learn the new limits of his body. One of them, jarringly, was his body’s inability to sweat.

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Why doesn’t the U.S. have more Black midwives?

STAT

Universities have also expanded their course offerings, with the number of new students enrolled in accredited midwifery programs growing from 1,006 students in 2014 to 1,214 in 2018 , according to the latest data available. more than doubled from 1991 and 2012 and has continued to grow steadily in the years since. Read the rest…

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STAT+: New NIH head says government has fallen behind pharma on clinical trials

STAT

Industry-sponsored trials increased 43% from 2006 to 2014, while newly registered NIH-funded trials decreased 24% over the same period. ” A Johns Hopkins University study published in 2015 showed that the pharmaceutical industry funds six times more clinical trials than the government. Continue to STAT+ to read the full story…

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STAT+: A Q&A with the CEO of CRISPR Therapeutics on a historic approval and the road ahead

STAT

Editas Medicine, CRISPR Therapeutics, and Intellia Therapeutics were all started in the 2013-2014 time frame with the same goal of turning the nascent CRISPR gene-editing technology into medicines.

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