2023 Complication Medical Provider 
Physician's Weekly
JUNE 19, 2025
When Alyne Diamond fell off a horse in August 2023 and broke her back, her employer-based health plan through UnitedHealthcare covered her emergency care in Aspen, Colorado. The insurer not only stopped paying current claims but also moved to claw back tens of thousands of dollars it had paid to providers in the two years since she turned 65.
FDA Law
OCTOBER 18, 2022
By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ).
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FDA Law
FEBRUARY 29, 2024
As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.
FDA Law
DECEMBER 13, 2023
Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development.
PEMBlog
APRIL 20, 2023
Rather, it can change the bleeding phenotype from severe hemophilia to mild hemophilia – thus potentially reducing the risk of complications. Patients on emicizumab will have it listed on their medication list. Epub 2023 Jan 16. Emicizumab, though, does not fully normalize hemostasis. How to know if a patient is on it?
PEMBlog
AUGUST 20, 2024
2023; 187:109792. So, eCPR, extracorporeal cardiopulmonary resuscitation, is an advanced medical procedure used in cases of cardiac arrest where traditional CPR has failed. So we need to include pre hospital providers, the emergency medicine teams. I hope that it provided a basic overview and some context. Am Heart J.
FDA Law
FEBRUARY 28, 2023
Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. There are additionally places to provide attachments for test reports and other supporting documents. By Adrienne R. New Labeling Requirements.
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