2019 Complication Individual IT 
FDA Law Blog
AUGUST 9, 2021
As you may remember, Genus sued FDA back in 2019, alleging that FDA’s classification of, and putative regulation of, its barium sulfate products as drug products violated the FDCA because barium sulfate meets the statutory definition of medical device and therefore must be regulated as a device.
FDA Law Blog
JULY 10, 2023
Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning.
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FDA Law Blog
MAY 17, 2022
But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s And with “must-pass” FDA legislation, comes a host of riders—pieces of FDA-related legislation not specific to UFA reauthorization, but that folks seek to get added to the UFA bill to address various issues and topics. Becerra.”
The Clinical Problem Solvers
APRIL 5, 2022
Push back against individual narratives that blame individuals for systemic injustice. Dr. Kushel detailed how the use of dehumanizing language equates to complicity in a narrative that systemically harms our neighbors with lived expertise in homelessness. Published April 5, 2019. January 18, 2019. Rothstein, R.
The Clinical Problem Solvers
FEBRUARY 8, 2023
Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.
GeriPal
MARCH 9, 2023
In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. Theora Cimino conducted an observational study (publication in the works) of marginally housed/homeless persons many of whom had experience with psychedelics. And yet there are reasons for caution. Alex: Yeah, yeah, it does.
GeriPal
AUGUST 25, 2022
I had looked at a research article that had recently evaluated the prevalence of private equity transactions in the hospice market and noted that there was a pretty substantial uptick in the past decade, and really over the course of say around 2015 to 2019. We’re going to be talking about each one of these papers. Is it you, Melissa?
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