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Foley & Lardner
On May 6, 2024, the U.S. Food and Drug Administration issued its final rule significantly modifying FDA's approach to oversight of laboratory developed tests.
Arnold & Porter
Earlier this month, the Seventh Circuit issued an opinion addressing a few issues of note for our Qui Notes readers, including the circuit split on the causation standard for a False Claims Act (FCA)...
Providers must optimize the risk-based primary care model following the end of an era marked by M&A expansions and large capital expenditures.
Holland & Knight
The U.S. Drug Enforcement Administration (DEA) on May 16, 2024, issued a proposed rule to move marijuana from its current classification as a Schedule I drug to a Schedule III drug...
Goodwin Procter LLP
Earlier this month, FDA approved Boehringer Ingelheim's high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab).
Goodwin Procter LLP
Earlier this year, Indiana joined a growing number of states by enacting a new notification requirement for certain healthcare transactions. Indiana Senate Bill Number 9 (SB 9)...
Goodwin Procter LLP
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs)...
Duane Morris LLP
On April 29, 2024, the U.S. Food and Drug Administration announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests, including laboratory developed tests, are devices regulated under the Federal Food, Drug and Cosmetic Act.
New rule creates premarket review, reporting, quality system, and other requirements for laboratory developed tests...
Kaufman Rossin
Panelists at ACG South Florida's Healthcare M&A Panel in February discussed preparing companies for a sale, EBITDA addbacks and sector trends. Panelists at ACG South Florida's 16th Annual Healthcare...
Manatt, Phelps & Phillips LLP
This study uses publicly available data to examine the financial structure and performance of acute hospitals and health systems in Rhode Island (RI) and compare trends with Connecticut (CT) and Massachusetts (MA).
Davis Wright Tremaine
Aetna recently announced that it is rolling out a national protocol under which it will be reviewing both physician and hospital emergency department claims that include Level 4 or 5 evaluation ...
Ankura Consulting Group LLC
In the latest episode of the Ankura podcast, Michelle Mader, Ankura Healthcare Strategy expert, and Ray Anderson, Chief Strategy Officer of Trinity Health offer their insight...
Arnold & Porter
Life Sciences & Healthcare Regulatory practice co-chair Mahnu Davar was quoted in the Bloomberg Law article, "FDA Lab Test Authority Set for Compliance Hurdles, Legal Fights." The article discusses the U.S. Food...
Oblon, McClelland, Maier & Neustadt, L.L.P
Clinical trials are a critical part of the development and approval process for drugs, biologics, and medical devices. The lengthy and public nature of clinical trials, however, can create challenges...
Arnold & Porter
In our blog post on 22 February 2024 we reported on the Medicines and Healthcare products Regulatory Agency (MHRA) announcement that it intended to launch a regulatory sandbox for software and AI medical devices called the "AI-Airlock".
Arnold & Porter
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to artificial intelligence (AI).
Crowell & Moring LLP
Talc is a mineral ingredient used in many cosmetic and personal care products, including baby powder, root touch-up products, and blush.
Manatt, Phelps & Phillips LLP
On May 8, the House Committee on Ways and Means (W&M) held a markup to consider six health-related bills. All of the bills were reported favorably out of the committee.
Arnold & Porter
On May 6, 2024, the FDA published its highly anticipated final rule, which was formally published in the Federal Register on May 6, revising the regulatory definition of an IVD product to explicitly capture IVDs manufactured by laboratories.
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