The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products.
The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more
11/3/2023
/ Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
Off-Label Promotion ,
Off-Label Use ,
Online Platforms ,
Pharmaceutical Industry ,
Real World Evidence
Senators Focus Attention on Litigation Funding’s Opacity -
Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more
10/31/2023
/ CERCLA ,
Compliance ,
Consolidated Appropriations Act (CAA) ,
Cybersecurity ,
Environmental Protection Agency (EPA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Investment ,
Litigation Funding ,
Medical Devices ,
PFAS ,
Political Campaigns ,
Proposed Legislation ,
Regulatory Oversight ,
SCOTUS ,
Social Media ,
Third Party Funding ,
Toxic Substances Control Act (TSCA) ,
Transparency ,
Vulnerability Assessments ,
Wireless Technology
Delaware Supreme Court Rejects No-Injury Medical Monitoring Claims -
As part of our ongoing coverage of issues in Medical Monitoring, we noted that the Delaware Supreme Court received a certified question from the U.S....more
10/2/2023
/ Air Pollution ,
Appeals ,
DE Supreme Court ,
Draft Guidance ,
Environmental Protection Agency (EPA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Rules of Civil Procedure ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Medical Monitoring ,
Motion to Exclude ,
OECA ,
PFAS ,
Software