Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more
10/29/2015
/ 510(k) RTA ,
CLIA ,
Clinical Laboratories ,
Diagnostic Tests ,
Due Diligence ,
Duty of Candor ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Intellectual Property Protection ,
Laboratory Developed Tests ,
Lack of Novelty ,
Medical Devices ,
New Guidance ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Personalized Medicine ,
Premarket Approval Applications ,
Proposed Regulation ,
Risk Mitigation ,
USPTO
Legal News: Eye on China Quarterly Newsletter offers companies helpful insight as they successfully navigate China’s complex and ever-changing legal and regulatory environment. In this issue, we focus on the following...more
4/30/2013
/ Anti-Bribery ,
Anti-Corruption ,
China ,
Compliance ,
Copyright ,
Foreign Corrupt Practices Act (FCPA) ,
IBM ,
Inventors ,
Multinationals ,
Patents ,
Pfizer ,
Trade Secrets