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
In FDA regulatory matters, companies must carefully choose when to challenge the government, and when to comply. In a recent case, Whoop, the Boston-based wearable maker, has chosen to openly challenge the U.S. Food and Drug...more
Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more
The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas...more
Yesterday, the U.S. Food and Drug Administration (FDA) granted “full approval” to the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. In other words, the Pfizer-BioNTech vaccine (which will now be...more
On August 23, 2021, the U.S. Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine. Moderna’s expedited application for full approval is still pending, and Johnson & Johnson plans to submit its...more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
2019 Filings - In 2019, the number of securities class action cases filed against life sciences companies reached record levels. According to Cornerstone Research, lawsuits against pharmaceutical companies increased by 40...more
When regular citizens get together in the civil justice system to deliberate difficult claims about complex matters, they may not get everything just right to the satisfaction of the disputing parties. But jurors’ wisdom and...more
2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more
A number of important changes have occurred in the cannabis, hemp, and cannabidiol (CBD) spaces. This alert presents a snapshot of significant developments and selected future predictions....more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more