AGG Talks: Healthcare Insights Podcast - Episode 2: Substance Use Disorder Litigation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim Dall, Healthcare Economist
The Presumption of Innocence Podcast: Episode 29 - A Global Perspective on the Economic Responses to COVID-19
Podcast: Telehealth Post-Public Health Emergency – What to Expect in 2024 – Diagnosing Health Care
Meeting Cancer Reporting Requirements
Changing Telehealth Rules
Taking the Pulse: A Health Care and Life Sciences Video Podcast - Ep. 111 with Will Britt, Chief Counsel for Public Health, SC DHEC
USDA FSIS Proposes to Declare Salmonella an Adulterant in Breaded Stuffed Raw Chicken Products
PFAS Regulatory Update: EPA Issues Updated Drinking Water Health Advisories
Where Do We Stand on COVID-19? A Conversation with Andy Slavitt
Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
#WorkforceWednesday: Evolving Pandemic Regulations, Overtime Rule Under Review, ACA Upheld - Employment Law This Week®
#WorkforceWednesday: States Adjust COVID-19 Regulations and OSHA ETS Released - Employment Law This Week®
Forever Chemicals: What They are and What is being Done to Minimize Their Impact
The CDC's Guidance for Fully Vaccinated People
What Can Businesses Do After Texas Lifts the Mask Mandate?
COVID-19 Vaccines: The Ethical and Legal Challenges to Immunization
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Chicago Mayor Lori Lightfoot on Policing Reform
#WorkforceWednesday: CDC Permits Shortened Quarantine Periods, CAL/OSHA COVID-19 Regulations, NY Amends WARN Act - Employment Law This Week®
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more
L'arrêté ministériel fixant la Charte relative à la qualité des pratiques professionnelles de présentation, d'information ou de publicité des dispositifs médicaux à usage individuel, des autres produits de santé et de tout...more
The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated...more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more
Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016... The 21st Century...more
According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath. Instead of relying on a lab, the...more
Nephros, Inc. acquired GenArraytion, Inc., a manufacturer of infectious disease monitoring and measurement products. The acquisition is Nephros’s first medical products sector transaction....more
In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more
Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced that it published a list of 223 drug and...more
Since early this year, the COVID-19 virus substantially affects our daily life. Testing for the presence of or past exposure to the virus is an essential aspect of combatting the COVID-19 outbreak and a number of companies...more
Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
COVID-19 is transforming the way businesses create products and go-to-market, especially when launching health products during a pandemic, on an expedited timeline. How are they managing the regulatory requirements and public...more
The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment...more
As part of the U.S. government’s response to the COVID-19 pandemic, on March 10, 2020, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness...more
In the ongoing effort to reduce in-person contact and exposure during the coronavirus pandemic, this week FDA released the guidance document "Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During...more
Given the challenges in maintaining the supplies of healthcare materials such as surgical masks and FFP2 and FFP3 face masks, the Belgian Task Force on shortages, a working group set up by the Belgian Federal Agency for...more
China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....more
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion...more