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
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...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
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
On March 30, 2020, CMS issued additional Section 1135 blanket waivers to provide the American healthcare system with additional flexibility to respond to the COVID-19 pandemic. CMS is authorized under Section 1135 of the...more
On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more
To combat shortages of N95 respirators, the Centers for Disease Control and Prevention issued and continues to update its Strategies for Optimizing the Supply of N95 Respirators. The CDC’s N95 Respirator Strategies provide...more
To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more
The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more
The civil justice system, by regularly closing off and keeping secret key parts of lawsuits involving medical devices and prescription drugs, may contribute to patients’ serious injuries and deaths, according to a “special...more
Pro Te: Solutio returns for its second edition of 2019. As the year grinds on, our attorneys at Butler Snow are taking proactive and creative steps to confront and solve the issues that affect our areas of practice. The...more
On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment. ...more
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more
Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more