The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in guidance for COVID-19 master protocols
Life Sciences Perspectives
Life Sciences Perspectives, published by Goodwin Procter, focuses on legal and regulatory developments affecting the life sciences sector. The blog covers topics such as pharmaceutical and biotechnology transactions, regulatory compliance for drugs, biologics, medical devices, diagnostics, and laboratory testing. It also addresses antitrust issues, healthcare fraud enforcement, data privacy regulations like the EU Data Act, and FDA programs impacting drug development and approval. The blog provides updates on policy changes, enforcement trends, and strategic considerations for companies and investors operating in the life sciences and medtech industries.
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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 navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics,…
FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule
On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding regulations under development by federal agencies. In its preamble…
A Practical Look at OIG’s New Compliance Guidance
By Publisher
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 does not set new…
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 Notice involving 340B Program “child site” registration and eligibility; and (2) a…
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 price transparency laws creating new requirements…
United States: Trends of Agency Scrutiny on Pharmaceutical Transactions Expected to Shift Amid Rise in Deal Activity (GCR)
Despite the threatening rhetoric, the early years of the Biden Administration largely followed previous regimes with respect to antitrust enforcement in the life sciences space. Pharmaceutical transactions in particular encounters the expected amount of agency scrutiny, with most proceeding without…
Newly Launched: Goodwin’s Laboratory Developed Tests Resource Page
Our Life Sciences Regulatory & Compliance team has launched a new resource page, keeping you up-to-date on the latest regulatory developments affecting laboratory developed tests (LDTs). Our dedicated LDT page provides foundational materials, legislative and regulatory history, and updates and…
Antitrust & Competition Life Sciences Quarterly Update Q3 2023
The third quarter in the life sciences space saw notable developments in significant agency enforcement actions:
- The FTC abandoned its pursuit of a novel theory and settled its Amgen/Horizon lawsuit 10 days before the scheduled preliminary injunction hearing. As detailed
…
How to Get Your SIUU Out: FDA Provides Long-Awaited Update for Industry on Communicating Off-Label Information
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 Approved/Cleared Medical Products.” The draft guidance supersedes the agency’s 2014 draft guidance,…