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
Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more
In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...more
The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more
On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more
In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more
Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider...more
In this webinar, we’ll discuss what we know about FDA regulation of cannabis and cannabis-derived products and look at trends in recent FDA enforcement over CBD products. Topics include: - Pathways for FDA...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
Laboratory Developed Tests and Their Regulation - Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more
For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more
The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the...more
A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more
At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more
We’ve previously blogged about the regulation of CBD by the Food and Drug Administration (FDA), and it appears that the dialogue around CBD isn’t slowing down as we continue through the second half of 2019. Recently, a...more
McDermott’s cross-functional team of life sciences professionals present the inaugural Chicago-Area Life Sciences Bootcamp focusing on issues and trends important to life sciences companies....more
McDermott’s cross-functional team of life sciences professionals present the second annual Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more
In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter...more
In this issue of Pro Te (Volume 11, No.2), we examine three important topics with practical implications. In many jurisdictions, the medical judgment of physicians is almost sacrosanct – at least insofar as it is...more