STAT
MAY 1, 2024
In March 2020, as Bauman was preparing to undergo the surgery at a Mount Sinai medical facility in midtown Manhattan, he said he was invited to participate in a research study — one only open to patients already committed to undergo DBS at Mount Sinai.
STAT
OCTOBER 16, 2024
But the underlying message to doctors in late 2020 was persistent and urgent: Hit your targets to see more patients. But inside a UnitedHealth practice, the “#1 PRIORITY” became documenting older patients’ chronic illnesses to generate more revenue from the federal government, the emails show.
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Drug Channels
DECEMBER 14, 2021
This year, we review 2020 data on commercial plan sponsor clients of CVS Health and Express Scripts along with two smaller PBMs—Navitus and WellDyne. I document this disappointing state of affairs below. Click here to see the original post and comments from July 2021. I’m sad to report that this year’s analysis is skimpier than usual.
ALiEM - Pharm Pearls
MARCH 29, 2023
Children 29 days or older with fever from a documented viral source can be managed according to their clinical presentation and can go outside the algorithm. This requires a documented positive viral swab and not just a presentation consistent with a viral syndrome. 2020 Dec 17:hpeds.2020-0187. Epub 2020 Oct 31.
FDA Law Blog: Biosimilars
FEBRUARY 23, 2025
Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Notably, FDAs public WL database only goes back to 2020. See 21 C.F.R.
European Pharmaceutical Review
AUGUST 23, 2022
A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.
Eye on FDA
AUGUST 18, 2020
But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019.
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