Episode 335 -- The New DOJ Whistleblower Program
Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
AGG Talks: Women in Tech Law Podcast - Episode 3: Cybersecurity and FCA Compliance: Essential Insights for Tech Leaders
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
#WorkforceWednesday®: New DOJ Whistleblower Program - What Employers Must Know - Employment Law This Week®
The Presumption of Innocence Podcast: Episode 43 - New Horizons: Impact of Recent Appellate Circuit Rulings on White-Collar Criminal Defense Law
Redlining Isn’t What it Used To Be
Episode 333 -- The Boeing Proposed Plea Agreement
DOJ’s New Self-Disclosure Policy and Corporate Whistleblower Awards Pilot Program
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
FCPA Survival Guide - Step 8 - Investing in Compliance
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
Episode 328 -- Sanctions Enforcement Risks and Redlines
Common Scenarios Triggering False Claims Act Violations, Part 1: Gov. Contracts and Cybersecurity
Cannabis Law Now Podcast: What’s Next for Schedule III Marijuana
Redlining Complications Caused by Implementation of 2020 Census Tracts
FCPA Survival Guide: Step 3 - Extensive Remediation
Episode 324 -- Third-Party Risks and Sanctions Compliance
The Justice Insiders Podcast: DOJ’s Cacophony of Whistles
The Latest on Healthcare Enforcement
In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more
Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more
On December 3, 2020, the Federal Trade Commission (FTC) published its annual report on pharmaceutical patent settlements filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003...more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more
Here are our picks for the most significant U.S. regulatory developments related to biosimilars in 2018: 1. FDA Releases Biosimilars Action Plan - In July, FDA released the Biosimilar Action Plan (BAP), which outlines...more
Recent amendments to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), titled the Patient Right to Know Drug Prices Act, require parties to inform regulatory authorities of executed settlement...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more
AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more
Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more