In January 2022, the U.S. Food and Drug Administration (FDA) released finalized guidance on premarket pathways for combination products.
While the guidance is not binding, it provides industry participants with valuable...more
Newsworthy Highlights -
FDA and CDC Issue Warnings on Delta-8 Use. In response to a marked uptick in reported adverse reactions and hospitalizations, the U.S. Food and Drug Administration (FDA ) and the Centers for Disease...more
A Jan. 27, 2021, McGuireWoods article discussed the Federal Trade Commission’s crackdown on deceptively marketed cannabidiol (CBD). The focus of the inquiry was to “send a clear message to the burgeoning CBD industry: Don’t...more
In episode three of McGuireWoods’ Edible Bites video series, the newly released U.S. Food and Drug Administration compounding pharmacy memorandum of understanding is hashed out, including discussion on key provisions and...more
While most cannabidiol (CBD) manufacturers and sellers focus on the U.S. Food and Drug Administration (FDA), federal agencies outside the FDA have put their focus on the CBD industry....more
McGuireWoods’ Edible Bites video series serves up important information from the cannabis and life sciences industries. Episode two explores FDA guidance on microneedling products....more
As the hemp-related product industry continues to grow, institutional lenders now have clarifying guidance to consider as they conduct diligence regarding potential borrowers. Specifically, the National Credit Union...more
On July 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for sample pooling of specimens when using the SARS-CoV-2 rRT-PCR diagnostic test from Quest Diagnostics....more
This second McGuireWoods alert discussing regulation of hand sanitizer manufacture and distribution addresses new considerations from the Food and Drug Administration (FDA) published in a June 2020 update to its March 2020...more
Blasting off into summer, the U.S. Food and Drug Administration (FDA) is soliciting feedback from the industry about what they would want to see added to the Orange Book. FDA’s Orange Book (also known by its less-used formal...more
During the COVID-19 pandemic and national emergency, the U.S. Food and Drug Administration (FDA) has taken a relatively relaxed approach to some of the more concrete regulations governing the nation’s food supply. This month,...more
COVID-19 has forced the healthcare system to adapt to a unique set of circumstances. As reported in prior McGuireWoods updates, a number of state and federal developments have affected the practice of pharmacy during the...more
The COVID-19 emergency has impacted all aspects of the food and beverage industry, and restaurants are no exception. Realizing the essential economic and food service roles restaurants play — and that restaurants’ needs have...more
To provide relief during the coronavirus (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) announced on March 24, 2020, that it will not enforce certain veterinarian-client patient relationship (VCPR)...more
With COVID-19 dominating headlines and food manufacturers struggling to ensure that grocery store shelves remain stocked during this pandemic, manufacturers may have missed an important update from the U.S. Department of...more
A complete overhaul to the over-the-counter (OTC) drug system quietly rode its way into law with the Coronavirus Aid, Relief, and Economic Security Act or the CARES Act (H.R. 748), along with several other significant reform...more
With the COVID-19 pandemic, the demand for hand sanitizer is extremely high, and the supply chain has not kept pace with that demand. In an effort to meet public need, several federal agencies, including the Food and Drug...more
As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to...more
In light of the urgent need for medical intervention during the coronavirus pandemic, the Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control...more
The COVID-19 pandemic has brought a cascade of statements from the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Below are summaries of some of the more pertinent statements...more
During the COVID-19 (coronavirus) national emergency, the Food and Drug Administration and U.S. Department of Agriculture continue to emphasize measures intended to keep the food supply safe....more
Consumers may not think of salmon as a drug, but according to a recent opinion out of the Northern District of California, certain genetically modified (GMO) salmon qualify as drugs under the Food, Drug, and Cosmetic Act...more
On Jan. 15, the Subcommittee on Health of the Committee on Energy and Commerce held a legislative hearing to discuss cannabis policy. The focal point of most of the hearing was about research into marijuana, its extracts and...more
At last month’s MJBizCon, the premier gathering for cannabis and hemp industry experts, investors and industry professionals addressed cutting-edge issues in this rapidly expanding market....more
The U.S. Food and Drug Administration (FDA) recently released a draft guidance document regarding transdermal and topical delivery systems, outlining the agency’s thoughts on process and product development. FDA considers...more