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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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Agitation Podcast Series Episode 5: Management of the child with mental health problems who is boarded in the ED

PEMBlog

Government. Children’s Mental Health Emergency Department Visits: 2007-2016. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources. Pediatrics. 2021;147(5):e2020030692. doi: 10.1542/peds.2020-030692 Pediatrics. 2020 Jun;145(6):e20191536.

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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). use in education, construction, art, and jewelry).

Medical 98
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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). use in education, construction, art, and jewelry).

Medical 75
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What is going on with MAID in Canada? Bill Gardner, Leonie Herx, & Sonu Gaind

GeriPal

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. In 2016 there were about a thousand MAID deaths, in 2021 there were about 10,000. Four percent. AMA PRA Category 1 credit(s) ™. Eric: Yeah. Eric: Please.

Illness 144
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Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law

We thought that it would be educational and entertaining to list the Top Ten reasons presented in letters from three high profile stakeholder groups to Attorney General Merrick Garland and/or DEA Administrator Anne Milgram on how to handle the scheduling recommendation. In other words, no rescheduling.

Medical 59
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Aging and Homelessness: Margot Kushel

GeriPal

You add to that employment discrimination, criminal justice discrimination, and of course educational system discrimination, and of course, we pay for our public schools based on local taxes. In what moral universe is a federal government deeply subsidizing my housing and not subsidizing that of my patients? Margot: Yeah. That was me.