XTalks

DECEMBER 14, 2023

We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the FDA’s news release. “We It is used at home and in clinical settings.

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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XTalks

JUNE 12, 2023

Medtronic, the leading global medical device manufacturer, reported a revenue growth of 5 percent in the last fiscal year, affirming its position as the top global medical technology company by revenue. This article takes a comprehensive look at the top 10 medical device companies that are leading the charge in this rapidly evolving field.

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The Pharma Data

OCTOBER 22, 2020

The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply. Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the United States.

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FDA Law Blog

OCTOBER 10, 2022

As a refresher, the Cures Act established the following four criteria for Non-Device CDS software: Criterion 1 : Non-Device CDS software functions do not acquire, process, or analyze medical images, signals from an in vitro diagnostic (IVD) device, or patterns or signals from a signal acquisition system.

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The Pharma Data

MARCH 17, 2021

The PRO analysis included patients in both arms of the study and measured their experiences with side effects, symptoms, and health-related quality of life, in those receiving Verzenio plus ET versus ET alone. The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference.

HR 52

HR Trials In-Vitro Manufacturing 52

FDA Law Blog

FEBRUARY 20, 2025

Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs. Mullen & Jeffrey N. Judge Jordan said he would issue a decision as soon as possible.

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