Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more
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
Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more
In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more
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. ...more
This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more
On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation (Novartis)...more
Too many of us don’t enjoy life to the fullest because our health is lagging. In fact, the federal Centers for Disease Control and Prevention estimates that 6 in 10 U.S. adults have a chronic disease and 4 in 10 have two...more
Colorado and New York are not waiting for the Fair Credit Reporting Act rulemaking to eliminate creditor use of medical debt announced by the CFPB in September 2023. As we previously blogged, in the past two years, Equifax,...more
Idaho’s new Virtual Care Access Act (the “Act”) amends Idaho’s existing law to make it easier to render telehealth in Idaho effective July 1, 2023. The requirements of the new Act are summarized below....more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
In 2021, drug-related overdose deaths topped 107,000. Despite a nearly 50% decrease in opioid prescribing over the past decade, drug overdose mortality continues to trend in the wrong direction. Of particular concern is that...more
Lawmakers unveiled their long-awaited $1.7 trillion government funding package on Dec. 20, 2022. As of publishing, it seems likely that a vote on final passage in the U.S. Senate will occur at some point on Dec. 22, with a...more
In 2021, drug-related overdose deaths topped 107,000. Despite a nearly 50% decrease in opioid prescribing over the past decade, drug overdose mortality continues to trend in the wrong direction. In the face of these...more
In 2021, drug-related overdose deaths topped 107,000. Despite a nearly 50% decrease in opioid prescribing over the past decade, drug overdose mortality continues to trend in the opposite direction. In particular, drug-related...more
In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more
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. This week's topics include... ...more
Prompted by rising rates of overdose deaths, suicides and incidence of mental illness in at-risk populations, such as children, Congress has spent the better part of the year working in a bipartisan manner to develop and...more
On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more
(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more
L'arrêté ministériel fixant la Charte relative à la qualité des pratiques professionnelles de présentation, d'information ou de publicité des dispositifs médicaux à usage individuel, des autres produits de santé et de tout...more
The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated...more
In October of 2018, Congress passed the SUPPORT for Patients and Communities Act (P.L. 115-271). The comprehensive opioid treatment law passed both chambers of Congress with large bipartisan support and tackled many aspects...more