News & Analysis as of

Food and Drug Administration (FDA) Supply Shortages Manufacturers

Harris Beach Murtha PLLC

GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding

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

Foley & Lardner LLP

GLP-1 Drugs: FDA “Re-Confirms” Decision Removing Tirzepatide from the Drug Shortage List

Foley & Lardner LLP on

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

Hendershot Cowart P.C.

Novo Nordisk Urges FDA to Ban Compounded Semaglutide – What Weight-Loss Clinic Owners Need to Know

Hendershot Cowart P.C. on

Novo Nordisk, the manufacturer of Ozempic and Wegovy, has petitioned the Food and Drug Administration (FDA) to add semaglutide, the active ingredient in Wegovy and Ozempic, to the "Demonstrable Difficulties for Compounding"...more

King & Spalding

CMS Issues IPPS and LTCH Proposed Rule for FY 2025

King & Spalding on

On April 10, 2024, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule for Fiscal Year (FY) 2025 (the Proposed Rule). In...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

Foley & Lardner LLP on

As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

American Conference Institute (ACI)

[Event] Legal, Regulatory & Compliance Forum on Dietary Supplements - June 29th - 30th, New York, NY

American Conference Institute in collaboration with the Council for Responsible Nutrition (CRN) are excited to welcome you back to New York for the “return to live” reunion that the dietary supplements industry has been...more

Sheppard Mullin Richter & Hampton LLP

FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems

The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework to evaluate the Quality Management...more

BakerHostetler

Companies Entering the Disinfectant and Sanitizer Markets Should Proceed With Caution

BakerHostetler on

As COVID-19 swept across the country in March 2020, it became abundantly clear to anyone who visited a grocery store that the United States was facing a severe shortage of essential products. Among some of the more noticeable...more

Spilman Thomas & Battle, PLLC

The “Preventing Essential Medical Device Shortages Act of 2020”: COVID-19 Side Effect that Could Permanently Harm Medical Device...

The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the...more

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