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After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more
Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...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
The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023. COVID-19 EUA medical products and policies- As FDA...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
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
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...more
On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies...more
On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the...more
It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...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
With the surge of COVID-19 cases due to the Delta variant, many employers are considering whether to require employees to be vaccinated, how to encourage employee vaccinations, and the implications of vaccine policies for...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 a memo dated July 6, 2021, the DOJ’s Office of Legal Counsel concluded that the COVID-19 vaccines’ status as products authorized for emergency use does not prohibit public and private entities from requiring them as a...more
Yesterday, on July 27, 2021, the U.S. Center for Disease Control (CDC) issued new COVID-19 guidance, including recommending face masks even for vaccinated people when they are in indoor public settings in geographic areas...more
According to a legal opinion posted online on July 26, 2021, the U.S. Department of Justice officially took the position that the Food, Drug, and Cosmetic Act (FDCA)—which authorizes an “emergency use authorization” (EUA) for...more
Can employers mandate vaccines? The Department of Justice’s Office of Legal Counsel (OLC) says they can, but before employers do, they should consider the many legal and practical risks. On July 26, 2021, the OLC issued an...more
Emergency Use Authorizations will play a role as the pandemic eases, but a transition to ordinary course approvals is underway. As long as the COVID-related emergency is deemed to exist, fast-tracked FDA regulatory...more
On June 4, 2021, a federal judge denied a request for a temporary restraining order that would have blocked Houston Methodist Hospital (the “Hospital”) from requiring its employees to receive one of the currently-available...more
In a pair of notable new lawsuits, employees of both public and private employers have filed legal challenges to mandatory COVID-19 vaccination policies. First, on April 16, 2021, in the Middle District of North Carolina, a...more
Happy New Year! As we move into 2021, we know that many of you are considering whether to require employees to get the COVID-19 vaccination. The current COVID-19 vaccines have received Emergency Use Authorization (“EUA”)...more
Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more
On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more