False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
As the page turned on 2025, optimism was high among life sciences dealmakers. Elections in the U.S. and other major economies had concluded, interest rates were poised to come in to focus, and the regulatory environment...more
Unfortunately, the risk of a cancer diagnosis is a very real concern with many common (and not-so-common) medications. While drug companies have a legal duty to ensure that their medications are safe, these companies don’t...more
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more
The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more
On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more
The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more
Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
On May 22, 2025, the FDA approved Bio-Thera Solutions and Hikma Pharmaceuticals’ ustekinumab biosimilar, STARJEMZA® (ustekinumab-hmny) injection, referencing Janssen’s STELARA® (ustekinumab) injection....more
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more
Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more
The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and...more
President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical...more
The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...more
Abbreviated New Drug Applications and 505(b)(2) Applications - This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug...more
Reported settlements in federal district court cases - This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant...more
New Drug Applications and 505(B)(2) Applications - This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more
Yutrepia® (treprostinil inhalation powder) - Case Name: Liquidia Techs., Inc. v. FDA, No. 24-2428 (D.D.C. Feb. 27, 2025) (Kelly, J.) Drug Product and Patent(s)-in-Suit: Yutrepia® (treprostinil inhalation powder) Nature of...more
Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more