Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
More plaintiffs are continuing to join the diabetes drug Ozempic lawsuits against Novo Nordisk; and, until a couple of weeks ago, some court watchers were estimating that the total number of federal lawsuits involving Ozempic...more
This year, a laboratory issued a report wherein it claims to have tested over-the-counter and prescription acne products containing benzoyl peroxide and found what it deemed to be “unacceptably high” levels of benzene. In...more
As we reported in April, the United States Court of Appeals for the Ninth Circuit certified a question on California’s Learned Intermediary Doctrine in Himes v. Somatics, LLC, 2022 WL 989469 (9th Cir. Apr. 1, 2022). The...more
From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more
Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...more
Earlier this year, we discussed the Eastern District of Pennsylvania’s decision to enter a Lone Pine order – that is, a case management order that requires all plaintiffs to produce evidence establishing specific elements of...more
On opening an opinion, lawyers habitually roll their eyes when they see a table of contents. Even more so when they learn the opinion is over 300 pages. The MDL order granting defense motions to exclude experts and for...more
When there are multiple ANDA filers for the same drug, it may not be possible for a branded pharmaceutical company to bring Hatch-Waxman Act patent infringement suits against all of them in the same court consistent with the...more
The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more
Multidistrict litigation is often criticized for enabling plaintiffs to file meritless cases and then hide in large inventories, hoping to be swept up in a settlement (whether global or otherwise) before the case is...more
Centralization of claims in multidistrict litigation has become the new normal—so much so, that MDL proceedings now comprise more than 50 percent of the federal civil caseload. But has MDL practice in the United States...more
The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more
A judge in the United States District Court for the Southern District of Florida presiding over the In Re: Zantac (Ranitidine) Products Liability Litigation multidistrict litigation, MDL No. 2924, has held that state labeling...more
Join us as we celebrate the 25th Anniversary of ACI’s Annual Flagship Conference on Drug & Medical Device Litigation! ACI’s Drug and Medical Device Litigation has united the greatest minds of the pharmaceutical and medical...more
It’s back to business as usual for Commercial Division Justice Andrew Borrok, who recently issued a slew of decisions contributing to New York’s robust Commercial Division jurisprudence. ...more
Judges presiding over multidistrict litigations, known as MDLs, must walk a tightrope between individual and collective needs. ...more
A Kansas District Court recently reinforced that cases alleging claims outside the Judicial Panel on Multidistrict Litigation (JPML) Transfer Order cannot be employed to broaden the scope of the MDL litigation. In reaching...more
As the world grapples with the health crisis caused by COVID-19, litigation regarding a different health crisis - the opioid epidemic - continues to progress. In a major development last week for the multidistrict litigation,...more
Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more
We are excited to bring you issue 76 of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore what businesses need to consider when making climate-related...more
Editors’ Note: This is the second in our start-of-year series examining important trends in white collar law and investigations in the coming year. Our previous entry discussed SEC enforcement in 2020. Up next: a look at...more
Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more
This post is an update from our earlier blog post, available here, on the bellwether federal opioids trial in the Northern District of Ohio. Just hours prior to the start of the trial in a consolidated case involving two...more