On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more
A week before the EU’s AI Act comes into force on August 1, the White House announced that U.S. agencies have completed all actions required by President Biden’s AI Executive Order to date. Meanwhile, the Republican Party...more
It’s been a busy summer for the National Institute of Standards and Technology (NIST) and the U.S. AI Safety Institute (itself housed within NIST). July 26, 2024, marked the 270th day since President Biden issued his...more
Not to be left out of the international discourse on AI, on May 15, 2024, a bipartisan group of U.S. senators released a long-awaited “roadmap” for AI, detailing areas the Senate considers ripe for legislation and regulation....more
Regulatory, Legislative and Litigation Developments -
Federal Agencies and the White House Issue Six Month Update on AI Activities Outlined in President Biden’s Executive Order on AI. Since President Biden issued his...more
Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more
The American Conference Institute hosted its inaugural Life Sciences AI Summit in New York on February 21 and 22. The two-day conference brought together key stakeholders, including regulatory players such as FDA and the...more
A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more
1/5/2024
/ Class Action ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Human Genome Project ,
Life Sciences ,
Mallory v Norfolk Southern Railway Co ,
Mass Tort Litigation ,
Medical Devices ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
12/23/2022
/ Artificial Intelligence ,
Attorney's Fees ,
Causation ,
Class Action ,
Collective Redress ,
Consumer Fraud ,
EU ,
Failure To Warn ,
Federal Industry Standards ,
Food and Drug Administration (FDA) ,
Healthcare ,
Infringement ,
Litigation Funding ,
Medical Devices ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Privacy Laws ,
Regulatory Standards ,
Remedies ,
Settlement ,
State and Local Government ,
Statute of Limitations
Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more
Our latest briefing explores the FTC’s push to address “commercial surveillance” and data security, proposed rulemaking from HHS prohibiting the use of discriminatory clinical algorithms, a move by the CFPB to hold digital...more
The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the...more
As we ring in the new year, it is time, once again, to reflect on the most significant legal developments for our drug and device clients this year. Below is a brief recap and assessment of our top-five developments impacting...more
Faegre Drinker’s snap removal team continuously monitors snap removal updates across the country (for a basic explanation of snap removal and previous updates, see Faegre Drinker’s prior posts...; for a breakdown on how each...more
Faegre Drinker’s snap removal team closely monitors snap removal updates across the United States (for a basic explanation of snap removal and previous updates, see Faegre Drinker’s prior posts...; for a breakdown on which...more
On March 25, the U.S. Supreme Court decided Ford Motor Co. v. Montana Eighth Judicial District Court, revisiting the issue of due process limitations on the exercise of personal jurisdiction, most recently addressed by the...more
Pre-service removal—known colloquially as “snap removal”—continues to be adopted in more jurisdictions...
In Doe v. Daversa Partners, 2021 WL 736734, at *3 (D.D.C. Feb. 25, 2021), the U.S. District Court for the District...more
We don’t need to wait for the confirmation of Michael Regan as the new Administrator of the U.S. Environmental Protection Agency (EPA) to get the first look at how the Biden administration intends to regulate certain per- and...more
In a year where the use of “unprecedented” became routine, COVID-19 dominated just about every aspect of life, and its impact on drug and device law was no less encompassing. As we bid adieu and good riddance to 2020, we...more
The U.S. Environmental Protection Agency (EPA) is not immune from negligence claims that would “eviscerate” liability under the Federal Tort Claims Act (FTCA). So says United States District Judge Judith E. Levy in her...more