Biologic drug makers will soon have to alert the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) of agreements, including patent litigation settlements, they reach with biosimilar applicants. The new reporting requirement is part of the Patient Right to Know Drug Prices Act, which President Trump signed into […]
Source: Cooley LLP | Media | Alerts | China Piloting Drug Marketing Authorization Holder System
Source: Cooley LLP | Media | Alerts | US House Passes Judicial Redress Act to Facilitate Safe Harbor Negotiations
Cooley Alerts | No More Safe Harbor: What Should Life Sciences and Biotech Companies Be Doing to Transfer Data to the US?
Source: Cooley LLP | Media | Alerts | No More Safe Harbor: What Should Life Sciences and Biotech Companies Be Doing to Transfer Data to the US?
Cooley is excited to release a new resource for health care and life sciences companies: Key Considerations for Health Care Fraud Government Investigations/Inquiries. This quick reference documents provides a list of steps that companies should consider taking before a government investigation/inquiry occurs, and key steps to take if a becomes aware of a […]
Cooley is excited to release a new resource for health care and life sciences companies: 20 Key Considerations for Implementing an Effective Corporate Compliance Program. This quick reference document provides an overview of key areas that a company should consider as it seeks to implement and improve its corporate compliance programs. […]
Cooley Client Alert: HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs
The following Cooley Client Alert was released today. The PDF version is available here. On May 21, 2014, the United States Department of Health & Human Services Office of Inspector General (“HHS OIG”) issued a fifteen page Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs (“Supplemental Bulletin”) to […]
We informed you earlier this week that the U.S. Food and Drug Administration’s (“FDA”) long awaited final guidance on mobile medical applications was released. We have now published a Cooley Alert that analyzes the final guidance in greater detail. The Cooley Alert is available at: http://www.cooley.com/FDA-issues-final-guidance-regarding-mobile-medical-applications.