Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more
The Novavax COVID-19 vaccine recently received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for individuals 18 and older, making Novavax the fourth COVID-19 vaccine to receive either...more
(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more
Yesterday, the FDA authorized a second COVID-19 booster dose for Americans ages 50 and older, along with some immunocompromised individuals, at least four months after their initial booster....more
The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic....more
In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has also maintained its high priority focus on supporting innovation...more
In this special episode, Akin Gump labor and employment practice head Bob Lian and partner Lauren Leyden welcome noted epidemiologist Dr. Stephen Ostroff to update listeners on workplace issues related to coronavirus. ...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
The COVID-19 vaccine approval process reached a major milestone, but the fourth U.S. wave of the COVID-19 virus has prompted some sobering projections about the future of the pandemic. COVID-19 Vaccine Receives Full FDA...more
The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more
Over the past year and a half, employers have become all too familiar with various public health agencies and their regulations, recommendations, and preventative measures. For the past several months, a big question for...more
Due to the recent increase in COVID-19 cases, California officials are recommending that private employers require their employees to be vaccinated against COVID-19 or face regular testing. In an article in the Sacramento...more
The news this morning that the federal government fully approved the Pfizer COVID-19 vaccine could be a pivotal milestone in the fight against the coronavirus – especially when it comes to employers’ role in the battle. After...more
The proportion of employers mandating or considering mandating the COVID-19 vaccine increased nearly four-fold in the past three months, spurred by fears surrounding the Delta variant and the growing confidence that such...more
Although the COVID-19 vaccines are expected to receive full FDA approval – perhaps as soon as later this month – an increasing number of businesses are not waiting for full authorization and are pressing forward to require...more
On July 14, 2021, Governor Dewine signed House Bill (H.B.) 244 into law. The new law becomes effective 90 days after the governor’s signature. Under H.B. 244, public schools may not: ..Discriminate against an individual...more
In Washington: Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky urged parents to vaccinate adolescents and teenagers against the coronavirus Friday, adding that COVID-19 can be severe for this age...more
The Biden administration unveiled a new vaccine allocation strategy designed to address vaccine hesitancy and access issues. This new strategy coincides with a number of studies on COVID-19 variants that underscore the need...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 Tuesday's Report: FDA revokes...more
In Washington: Treasury Secretary Janet Yellen expressed confidence Wednesday that the U.S. can spend trillions more in upcoming legislation following this month’s $1.9 trillion coronavirus relief package. In testimony before...more
In Washington: The House of Representatives was set to pass its $1.9 trillion pandemic relief package (H.R. 1319), late Friday night over solid Republican opposition. The passage is a key step toward giving President Joe...more
In Washington: The Senate resumed former President Trump’s impeachment trial Wednesday. House impeachment managers presented a step-by-step timeline of the January 6 assault on the Capitol aided by new evidence. Senators saw...more
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more
On today’s episode, we explore the complex life cycle of the COVID-19 vaccine and some common questions surrounding the authorization, distribution and administration of the vaccination....more