Category: Cooley Alerts

Cooley Alert: Agreements Involving Biosimilars Must Be Reported to FTC and DOJ Under New Law

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 […]

Cooley LLP Alerts | FTC Enforcement Powers Limited in LabMD Data Security Case

Source: https://www.cooley.com/ftc-enforcement-limited-in-labmd-data-security-case

Cooley LLP Alerts | China Piloting Drug Marketing Authorization Holder System

Source: Cooley LLP | Media | Alerts | China Piloting Drug Marketing Authorization Holder System

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?

Resource Launch: Key Considerations for Health Care Fraud Government Investigations/Inquiries

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 […]

Resource Launch: 20 Key Considerations for Implementing an Effective Corporate Compliance Program

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 […]

COOLEY ALERT Published: FDA Issues Final Guidance Regarding Mobile Medical Applications

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.