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
On June 20, 2024, the California Occupational Safety and Health Standards Board partially adopted Petition 602—a proposal to require employers to provide opioid overdose reversal medications (e.g., naloxone) at all worksites...more
The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more
On March 22, 2023, the Minister of Health announced the first-ever National Strategy for Drugs for Rare Diseases. This strategy includes $1.5 billion invested to “increase access to, and affordability of, effective drugs for...more
Introduction- The International Narcotics Control Board (“INCB”) released its “Report of the International Narcotics Control Board for 2022 (E/INCB/2022/1)” (the “Report”), which dedicates an entire section to discussing the...more
Compliance with prescription drug controlled substances prescribing and dispensing rules is essential for pharmacies and prescribers, as penalties for non-compliance are severe and can result in State Board of Pharmacy and...more
The Equal Employment Opportunity Commission recently released two new technical assistance documents that address issues concerning the employment provisions of the Americans with Disabilities Act in relation to the use of...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
During the COVID-19 pandemic, employers have had to manage an ever-increasing variety of stressful employee related issues. However, as the crisis surges forward, with multiple states facing increased rates of infection as...more
As the Covid-19 pandemic slams the United States — with infections exceeding 100,000 and deaths spiking beyond 2,000 — the battle with the viral outbreak underscores the axiom that a crisis brings out true character, good...more
In response to the outbreak of a pneumonia-like disease caused by coronavirus (COVID-19), Chinese regulatory authorities adopted a few emergency measures under certain “Special Review and Approval Procedures” to fast-track...more
The civil justice system, by regularly closing off and keeping secret key parts of lawsuits involving medical devices and prescription drugs, may contribute to patients’ serious injuries and deaths, according to a “special...more
The blame and shame for the opioid-drug overdose crisis that kills tens of thousands Americans annually has moved to yet another set of individuals and institutions now — judges and courts that handled Big Pharma lawsuits and...more
Drug Manufacturing is Big Business - The Food and Drug Administration (FDA) has the responsibility to protect the health of U.S. consumers by ensuring food, drugs and medical devices are safe. The FDA also has a mission to...more
In the first case calling upon a court to interpret and apply Vanessa’s Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic...more
On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing...more
The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more