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Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
We previously reported on the FDA’s laboratory-developed test (LDT) rule published on May 6, 2024, which classifies LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This shift marks the end...more
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
From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more
The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more
On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in fiscal year 2023. While it is unclear if...more
During the ongoing COVID-19 pandemic, the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA or the Agency) issued a series of Emergency Use Authorizations (EUAs) and guidance...more
Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior...more
Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more
On April 16, 2021, the Food and Drug Administration (FDA) published twin notices in the Federal Register effectively reversing a move by the Trump administration Department of Health and Human Services (HHS) on January 15,...more
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the purpose of which is to provide emergency assistance and health care responses for individuals,...more
Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more
Note - On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more
Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more
On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more