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Ankura Consulting Group LLC
Over the past several years, legislators across the country have focused their attention on Pharmacy Benefit Managers (PBMs) due to concerns expressed over a variety of industry practices.
Goodwin Procter LLP
On March 5, Sandoz announced that the FDA approved its denosumab biosimilars, WYOST and JUBBONTI, as interchangeable with Amgen's XGEVA and PROLIA.
Foley Hoag LLP
In the USA, prescription drug advertising is primarily regulated by the US Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act)...
Sheppard Mullin Richter & Hampton
On February 16, the U. S. District Court for the District of Oregon struck down the state's drug price transparency law—The Prescription Drug Price Transparency Act (the "Act"...
Hyman, Phelps, & McNamara
Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts...
Hyman, Phelps, & McNamara
In 2009—15 years ago— the National Organization for Rare Disorders (NORD) announced the first U.S. recognition of Rare Disease Day.
Venable LLP
On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry.
Global Advertising Lawyers Alliance (GALA)
New York quietly proposed a bill intended to protect children from advertising of unhealthy foods and the disastrous health outcomes that follow...
Hyman, Phelps, & McNamara
The trio of CDER, CBER, and CDRH released a new draft guidance titled "Use of Data Monitoring Committees in Clinical Trials" that revises the 2006 guidance...
Hyman, Phelps, & McNamara
The American Conference Institute ("ACI") will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes.
AlixPartners
QoQ median revenue and EBITDA trended up for Health & Beauty, Home & Outdoor, and Apparel & Luxury, although it remained flat or trended down for Food & Beverage, Durables, and Packaging.
Mintz
The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump.
Kelley Drye & Warren LLP
Rest assured, you can stop worrying about ingesting ​"forever chemicals" when you use fast-food wrappers, microwave popcorn bags, and take-out paperboard containers.
Axinn Veltrop & Harkrider
Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable.
Arnold & Porter
Infectious disease and companion diagnostic IVDs reclassification push because of anticipated LDT final rule regulation.
Hyman, Phelps, & McNamara
As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products.
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.
Crowell & Moring LLP
The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation.
Perkins Coie LLP
On February 28, 2024, the U.S. Food and Drug Administration (FDA) announced that grease-proofing substances containing per- and polyfluoroalkyl substances...
Hyman, Phelps, & McNamara
Last Friday, the Delaware District Court rejected AstraZeneca's lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS's guidance implementing it.
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