On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more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