article thumbnail

Here are the major issues facing healthcare in 2021, according to PwC

Healthcare IT News - Telehealth

In March, as states were issuing stay-at-home orders, the FDA published pandemic-specific guidance for trial sponsors, institutional review boards and investigators on how to ensure the safety of their trial participants and reduce risks to trial integrity, while sustaining compliance with good clinical practice.”

COVID-19 213
article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

SQA

With the previous version of the Guide dating back to 2015, it was clear that a substantial overhaul of the text would be necessary to incorporate the technical progress and new policies that have been adopted in the intervening years. United States Food and Drug Administration (FDA) – Regulations and Guidances.

FDA 91
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Health Provider News

Hall Render

Louis nursing home lost major Medicaid cash infusion Crisis at north St. Louis nursing home: Residents displaced, staff left in the dark Employees without pay, residents displaced after largest St. health care spending hits $4.5 Accused Of Filing False Claims Settles For $14.7M

article thumbnail

Health Provider News

Hall Render

Here’s how to find quality care CEOs turn attention from recovery to growth ARKANSAS Statistics show many northern Arkansas locations considered maternity care deserts How broadband expansion is bolstering rural healthcare Arkansas leaders work to close gap between medical school graduates and in-state residencies Program in south Arkansas provides (..)

article thumbnail

Health Provider News

Hall Render

into cutting opioids in hospitals ISU and University of Utah partnership aims to combat Idaho’s mental health crisis Presbyterian-UnityPoint merger moves forward St. Mississippi Dept.

article thumbnail

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA 105