On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more
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. Below is a brief recap and assessment of a few of the top developments...more
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
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
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