Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
Most years are eventful for businesses regulated by the US Food and Drug Administration ("FDA"), and 2023 was no exception.
Seyfarth Shaw LLP
As foreshadowed in our earlier post, the first complaint was filed in what is expected to be a wave of litigation alleging breach of fiduciary duty in selecting and monitoring welfare plan vendors.
Arnold & Porter
On January 31, the U.S. Food and Drug Administration announced that the Center for Devices and Radiological Health intends to begin the reclassification process for most in vitro diagnostics that are Class III into Class II.
The Biden administration appears steadfast in its efforts to lower prescription drug costs and continues to explore multiple avenues...
Insulin costs lowered to $35 dollars per month for many patients this year as three major insulin manufacturers — Sanofi, Novo Nordisk...
On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA's Medicare Drug Price Negotiation Program...
The IRA's Medicare Drug Price Negotiation Program (the "Negotiation Program" or "Program"), which aims to lower drug prices by enabling the federal government to negotiate prices...
Our team's preparation for the year includes a review of the anticipated impact of the IRA on the health care industry in 2024.
Associates Joe Dages and Caleb Holland, and partner Joan Baughan co-authored an article titled "PFAS in food packaging: What were the key developments in the US in 2023 – and what is expected in 2024?".
Kerr Russell & Weber
There are several risks which physicians may encounter if they fail to comply with applicable laws and regulations, including disciplinary action against their medical license...
Scarinci Hollenbeck LLC
The Third Circuit Court of Appeals recently ruled in Logic Technology Development LLC v. FDA that the U.S. Food and Drug Administration (FDA) was within...
Hyman, Phelps, & McNamara
More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule.
Ropes & Gray LLP
On January 10, 2024, the Health Policy Commission ("HPC") released new FAQ guidance relating to the types of providers, transactions, and revenues that trigger a Notice of Material Change ("MCN") filing.
The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food...
Goodwin Procter LLP
Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis...
Foley & Lardner
In January 2024, Foley partner Jennifer Hennessy and PYA principal Barry Mathis addressed hot topics in health care privacy and cybersecurity...
Perkins Coie LLP
The U.S. Food and Drug Administration (FDA) recently published revisions to its multichapter draft guidance for industry on Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food...
In this episode, Ankit Gupta, CEO and founder of Bicycle Health, discusses his telehealth treatment program for opioid use disorder.
Hyman, Phelps, & McNamara
On Feb. 2, 2024, FDA's Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM).