Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
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
Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more
Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance...more
On July 12, 2022, The Equal Opportunity Employment Commission (EEOC) updated its guidance on the Americans with Disabilities Act (ADA) and the Rehabilitation Act as they relate to the pandemic. The new guidance recognizes...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA warns...more
On September 9, 2021, President Biden signed Executive Order 14042, "Ensuring Adequate COVID Safety Protocols for Federal Contractors," that directed agencies to include a clause in new contracts, options, and extensions...more
On September 17, 2021, the Safer Federal Workforce Task Force (the “Task Force”) issued updated guidance (the “Guidance”) to federal agencies about COVID-19 safety protocols for employees of federal contractors and federal...more
As we enter our seventeenth month of the COVID-19 pandemic, fears that the pandemic is once again getting out of control continue to rise. With COVID-19 cases increasing across the country, due in part to the contagiousness...more
In the first of what will likely be many cases addressing claims by employees fired for not obtaining a COVID-19 vaccination before returning to work, a federal district court in Texas upheld the employer’s vaccination...more
Many workplace leaders have been wondering, “Can we require employees to get the COVID-19 vaccine as a condition of employment?” According to a recent Ogletree Deakins benchmarking survey, most employers are not ready to...more
About half of the U.S. working age, vaccine-eligible population has now been vaccinated, according to Centers for Disease Control and Prevention (“CDC”) tracking data. New CDC guidelines allow the fully vaccinated to unmask,...more
Effective May 19, 2021, New York State will adopt the Center for Disease Control’s (CDC) Public Health Recommendations for Fully Vaccinated People (CDC Guidance). As Gov. Andrew Cuomo previously announced, the State on that...more
The Centers for Disease Control and Prevention (CDC) made waves this week with its announcement that fully vaccinated individuals can begin congregating indoors. Coupled with the announcement that teenagers are eligible for...more
An Emergency Use Authorization (EUA) is a mechanism used to enable the accessibility and use of medical countermeasures, including vaccines, during public health emergencies. Under an EUA, FDA may allow the use of unapproved...more
As noted, here’s a brief update pertaining to the new and updated guidance for developers of therapeutics, vaccines, and tests for COVID-19. These guidance outline FDA’s vision of a forward-looking, and flexible approach to...more
Based on welcome news that the COVID-19 vaccine may be available to the public in the coming months, many employers are beginning to consider whether mandatory vaccinations can be incorporated into existing strategies to...more
Conducting medical product clinical trials during the COVID-19 public health emergency presents unprecedented challenges. In light of the challenges presented by COVID-19, the Food and Drug Administration (FDA) issued...more
On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more