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
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more
Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more
In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars. Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without...more
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more
On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...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
On May 5, 2025, President Trump signed an executive order designed to increase U.S. capacity to manufacture drugs domestically. The order instructs the Food and Drug Administration (FDA) to...more
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more
Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more
The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024...more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
The Supreme Court of California is gearing up to decide an important question for the future of product liability law: Do drug manufacturers have a duty to innovate? In other words, does a manufacturer of a non-defective drug...more
On Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements. The exemptions followed...more
Ozempic and other diabetes-weight loss drugs have been linked to at least 162 deaths and 10,000 cases involving “serious” injuries since 2018, according to data from the U.S. Food and Drug Administration (FDA)....more
This year, a laboratory issued a report wherein it claims to have tested over-the-counter and prescription acne products containing benzoyl peroxide and found what it deemed to be “unacceptably high” levels of benzene. In...more
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more
The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their...more
On July 9, 2024, the Food and Drug Administrations (FDA) replaced a 10-year-old draft industry guidance on misinformation and social media information on prescription drugs and medical devices. The new guidance assists...more
The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more