Early access programs: how real-world data capture helps regulatory approval
While clinical trials can prove that a medical product is safe and effective in a controlled environment, the vital data for how a new medicine will perform in the real...
Category: Industry News
Closing the gap between real and synthetic data
Despite the massive opportunities that synthetic data brings to the table, one of the main challenges it faces is the reality gap that exists. BY SHRADDHA GOLED Synthetic data was listed...
22 recent hospital, health system executive moves
The following hospital and health system executive moves have been reported by or shared with Becker’s Hospital Review since Feb. 4: 1. Scott Puccino became CFO of New York City-based Weill Cornell Medicine. 2. Chase...
Industry cites outdated standards as flaw in FDA’s real-world data draft guidance
Posted 11 February 2022 | By Joanne S. Eglovitch The US Food and Drug Administration (FDA) should adopt updated data standards that accommodate the “evolving and emerging” nature of real-world data...
EU ramps up collection of public health data to improve drug reviews
Feb 9 (Reuters) – The European Medicines Agency has set up a new centre to collect and mine more public health data from EU member states to improve the review...
CDER unveils 30 new planned guidance documents in 2022 agenda
Posted 07 February 2022 | By Jeff Craven About one-third of the guidance documents in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER)’s 2022 guidance...
CDC researchers use 2M patient records to shed new light on long COVID
A new study found that some COVID-19 patients were diagnosed with shortness of breath, Type 2 diabetes and fatigue weeks after their initial infection.By Kat JercichFebruary 07, 202203:58 PM Photo: SHVETS...
Fact Sheet: President Biden Reignites Cancer Moonshot to End Cancer as We Know It
FEBRUARY 02, 2022•STATEMENTS AND RELEASES Biden-Harris Administration Sets Goal of Reducing Cancer Death Rate by at least 50 Percent Over the Next 25 Years, and Improving the Experience of Living...
The Importance of Real-World Data in Cancer Care to Improve Patient Quality of Life
So much of cancer care is about time. When a clinician diagnoses a patient with cancer – particularly advanced cancer — there’s no time to waste. Treatment decisions that give...
How Digital Therapeutics Will Evolve in 2022 and Beyond
The digital therapeutics arena has been steadily gaining ground, backed by growing clinical evidence, and leaders in the space believe that it will become a new standard of care. Source:...