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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.
Jones Day
The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food...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The U.S. Food and Drug Administration (FDA) recently published revisions to its multichapter draft guidance for industry on Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food...
Fenwick
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).
Fenwick
Digital health is showing signs of life despite financial markets that seem determined to bring some of 2023's volatility into the new year. Stocks are up and down, and bond yields are climbing.
Venable LLP
In a significant stride toward expanding access to addiction treatment services, the Substance Abuse and Mental Health Services Administration (SAMHSA)...
Venable LLP
The Federal Drug Administration (FDA) regulates the marketing of a lot of things we use every day—dietary supplements, cosmetics, and medical devices.
Venable LLP
After a nearly two-year delay, the U.S. Department of Health & Human Services (HHS), through the Substance Abuse and Mental Health Services Administration...
Manatt, Phelps & Phillips LLP
On January 9, 2024, the Centers forMedicare and Medicaid Services (CMS) approved New York's request to amend its Medicaid section 1115 demonstration waiver, "Medicaid Redesign Team."
Sheppard Mullin Richter & Hampton
California's Legislature has been busy, proposing a number of bills that may affect California food retailers and manufacturers, should they be signed into law.
Goodwin Procter LLP
On February 12, the FDA issued a final rule regarding the use of Drug Master Files ("DMF") in Biologics License Applications.
Manatt, Phelps & Phillips LLP
Apparently in light of recent litigation against Medicare Advantage (MA) plans, on February 6, 2024, CMS published responses to frequently asked questions...
Crowell & Moring LLP
On February 12, 2024, Judge David Alan Ezra of the Western District of Texas dismissed a lawsuit challenging the constitutionality of the Drug Price Negotiation Program...
Barnes & Thornburg
A federal judge ruled in favor of the HHS-OIG and its interpretation of the Anti-Kickback Statute in an earlier published advisory opinion
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