News & Analysis as of

Medical Devices Pharmacy Benefit Manager (PBM)

Axinn, Veltrop & Harkrider LLP

Reflections on the 12th Annual Summit for Women Leaders in Life Sciences Law

We closed out July 2025 in Boston alongside several of our Axinn colleagues attending the American Conference Institute’s 12th Annual Summit for Women Leaders in Life Sciences Law. This conference is a highlight for us every...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - June 2025 #1

News Briefs - Healthcare M&A Expected to Rebound, Post-Acute Care to See Most - Economic uncertainties may have put a damper on healthcare M&A during the first quarter of the year, but many still expect a rebound as 2025...more

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q1

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While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - April 2025 #2

News Briefs - Judge Blocks Trump from Cutting Billions in State Health Funding - A federal judge said she will grant a request from 23 states to issue an emergency block on the federal government's rescindment of billions in...more

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

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Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - November 2023 #3

News Briefs - Senate Committee Advances Bill on 'Ghost Providers,' PBMs - In a unanimous 26-0 vote, the Senate Finance Committee passed a comprehensive draft package that puts pharmacy benefit manager reform and mental health...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2023 #1

News Briefs - More States Introducing 'Conscience' Healthcare Bills - A new Montana law will provide sweeping legal protections to healthcare practitioners who refuse to prescribe marijuana or participate in procedures and...more

White & Case LLP

Fraud and abuse risks in digital health: What tech companies need to know about healthcare enforcement – Part II

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For companies looking to monetize their hard-earned innovations in digital health, there is a minefield of potential healthcare enforcement to avoid. As discussed in Part I of this alert, such healthcare enforcement can lead...more

Faegre Drinker Biddle & Reath LLP

Patient Engagement Tools and Supports: Analysis of the New Anti-Kickback Statute Regulatory Safe Harbor

Providers have a new tool in their toolbox to promote population health. The Health and Human Services Office of Inspector General (OIG) has adopted a new, extremely broad safe harbor that allows certain providers to give...more

BakerHostetler

FDA and Pharmacy Weekly Digest - March 2020 #1

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Food/Dietary Supplements - FDA Extended the Comment Period for the Laboratory - Accreditation Program Proposed Rule – Once the laboratory accreditation program is established, the FDA will require that the testing of food...more

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #4

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Food/Dietary Supplements - FDA Provides Update on Frozen Berry Sampling – The FDA stated, “As of September 30, 2019, the FDA has tested 339 domestic samples and 473 import samples of frozen berries. ...more

BakerHostetler

FDA and Pharmacy Weekly Digest - January 2020 #2

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Food/Dietary Supplements - Court Enters Consent Decree Against Food Facility – A Michigan-based food manufacturer will “discontinue selling food products until the company complies with federal regulations and other...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

BakerHostetler

FDA and Pharmacy Weekly Digest - August 2019 #3

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Food/Dietary Supplements - FDA Remarks at National Industrial Hemp Council 2019 Hemp Business Summit – The Principal Associate Commissioner for Policy for the FDA stated, “We’ve seen rapidly growing interest in marketing...more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2019 #4

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Food/Dietary Supplements - FDA Announces Consent Decree Against Food Warehouse – A U.S. District Court in Arkansas entered a consent decree against a facility that warehoused food, drug products and medical products under...more

BakerHostetler

FDA and Pharmacy Weekly Digest - June 2019 #4

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Food/Dietary Supplements - FDA Announces Guidance on Added Sugar Labeling – The FDA published a new guidance for labeling of added sugars. ...more

BakerHostetler

FDA and Pharmacy Weekly Digest - June 2019 #2

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Food/Dietary Supplements - FDA Issues Produce Draft Guidance – The FDA published a draft guidance titled “Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for...more

BakerHostetler

FDA and Pharmacy Weekly Digest - May 2019 #3

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Food/Dietary Supplements - FDA Holds Public Meeting on Dietary Supplements – The FDA held a public meeting titled “Responsible Innovation in Dietary Supplements.” ...more

BakerHostetler

FDA and Pharmacy Weekly Digest - April 2019 #4

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Acting FDA Commissioner Holds First All-Hands Meeting – During his first all-hands meeting, Acting Commissioner Sharpless indicated that he would be revealing his priorities for the agency in the coming weeks. He stated that...more

BakerHostetler

Capitol Hill Healthcare Update

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Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. HOUSE PANEL TO VOTE ON BIPARTISAN DRUG PRICING MEASURE - The House Ways and Means Committee is scheduled to...more

BakerHostetler

FDA and Pharmacy Weekly Digest - April 2019 #1

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Food/Dietary Supplements - Public Meeting on Intentional Adulteration Rule – On April 17, 2019, the U.S. Food and Drug Administration (FDA) will hold a public meeting on the draft guidance it issued related to the...more

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