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
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
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more
The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD)...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
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
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
This regular update (no. 22 | 22 September 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...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
Over the past several months, the United States Food and Drug Administration (FDA) has issued several guidance documents and guidelines to regulate the importation and distribution of respirators for medical purposes during...more
Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or...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
Answers to frequently asked questions on who is eligible for PREP Act protections, which products are covered, and what activities will be immunized. PREP Act guarantees of immunity are available to those who manufacture,...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
In response to growing medical product supply shortages and need for information, the US Food and Drug Administration (FDA) has recently issued multiple enforcement policies to provide guidance to industry. Here, we focus on...more
On April 3, 2020, OSHA issued enforcement guidance that temporarily permits the extended and re-use of respirators as well as other alternatives, and clarifies when respirators, including N95 masks, may continue to be used...more
As recently as March 27, the WHO was stating on its website that there was insufficient evidence to suggest that the novel coronavirus was airborne except in a handful of medical cases, such as when intubating an infected...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