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On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more
From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...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
In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gardasil vaccine. Herlth v. Merck & Co., Inc., No. 3:21-cv-438 (JAM),...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...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
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
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
While requiring vaccinations for school attendance and in some occupations is common, the issue of employers requiring vaccination for COVID-19 is currently a hot topic. There is currently no Food and Drug Administration...more
The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more