Clik here to view.
Federal Court Strikes Down Copay Accumulator Programs
Summary: On September 29, 2023, the U.S. District Court for the District of Columbia vacated a Trump-era rule from 2021 that allowed insurers to exclude drug manufacturer co-pay support coupons and...
View ArticleClik here to view.
FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II:...
After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would...
View ArticleClik here to view.
Mark Your Calendars: This Halloween, Don’t Miss FDA’s LDT Webinar
The U.S. Food and Drug Administration (FDA) has announced an upcoming webinar on its proposed rule on the regulation of laboratory developed tests (LDTs). The webinar is scheduled for October 31, 2023...
View ArticleClik here to view.
Recent FDA Initiatives to Support Development of Individualized Cell and Gene...
Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities...
View ArticleClik here to view.
How to Get Your SIUU Out: FDA Provides Long-Awaited Update for Industry on...
On October 23, 2023, FDA announced the availability of a revised draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...
View ArticleClik here to view.
2023 State Drug Transparency Law Development Update
In October 2021, we reported on an uptick in the passage of state drug price transparency legislation. As an update to that report, as of October 2023, approximately 22 states have now passed drug...
View ArticleClik here to view.
Significant 340B Drug Pricing Program Litigation May Impact 340B Scope
Two recent federal court cases signal new significant developments with respect to the 340B Drug Pricing Program. Specifically: (1) new federal district court litigation challenging a recent HRSA...
View ArticleClik here to view.
A Practical Look at OIG’s New Compliance Guidance
On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG...
View ArticleClik here to view.
A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors...
View ArticleClik here to view.
Master(ing) Protocols for Randomized Umbrella and Platform Trials
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency...
View ArticleClik here to view.
A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors...
View Article
