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 February 24, 2024, the Drug Enforcement Administration (“DEA”) released a long-anticipated proposed rule that aims to permanently extend controlled substance prescribing flexibilities beyond the COVID-19 Public Health...more
At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more
Taking effect January 1, Oregon recently approved a temporary rule implementing SB 763, which requires licensure of pharmaceutical sales representatives who visit health care providers in the state of Oregon for 15 or more...more
On President Biden’s first two days in office, he issued a National Strategy for the COVID-19 Response and Pandemic Preparedness and 11 related Executive Orders, including an Executive Order on a Sustainable Public Health...more
The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more
The Connecticut Department of Consumer Protection Drug Control Division (DCP) has issued guidance for health care providers regarding refills and reissuances of controlled substance prescriptions for patients without an...more
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and Hydroxychloroquine Sulfate — to treat COVID-19. ...more
On March 24, 2020, the Massachusetts Commissioner of Public Health issued a Pharmacy Practice Order related to pharmacy practice by retail and institutional pharmacies....more
On March 12, 2020, an Appeals Panel of the United States Pharmacopeial Convention (“USP”) granted appeals to revisions of two compounding standards—General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparation...more
The Federal Drug Enforcement Agency (DEA) issued guidance permitting DEA-registered practitioners to prescribe controlled substances without an in-person medical exam of the patient for the duration of the COVID-19 public...more
The Ohio Board of Pharmacy (OBOP) is actively working to modify its rules or formulate temporary guidance and procedures to help combat the spread of COVID-19 (coronavirus) and aid in the delivery of pharmacy care to impacted...more
FEDERAL NEWS - The big news this week was the FDA’s report to Congress on CBD. The report did not set out a timeline for usage guidelines, citing the need for more data. Commissioner Stephen Hahn did indicate he thought...more
After months of unsuccessful mediation, Ohio Attorney General Dave Yost filed an amended complaint in the Franklin County Court of Common Pleas against pharmacy benefit manager (PBM), OptumRx. The complaint, which brings...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more
Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical licence....more
International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the...more
18 April 2019 Almost one and a half years after the launch of the sector inquiry, the French Competition Authority ("FCA") has released its conclusions on the functioning of competition in the pharmaceutical sector....more
On April 3, FDA Commissioner Scott Gottlieb released a statement outlining the agency’s priorities for 2019 with respect to compounding pharmacies and the compounding industry. ...more
On May 17, 2018, the Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used “certain ‘gaming’ tactics to delay generic competition.” The list is intended to...more
This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more
This is the first episode in a series focused on the legal issues surrounding the nationwide opioid crisis. To begin the series, Carla DewBerry discusses the laws and regulations impacting health care providers caring for...more
The European Medicines Agency (“EMA”) has replied to a letter from the European Ombudsman opening a strategic inquiry into EMA’s pre-submission activities....more
Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more