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340B Drug Pricing Program Compliance
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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
In February 2021, President Biden issued Executive Order 14017, “Executive Order on America’s Supply Chains” (discussed here), requiring (among other things) a report within 100-days requiring key government agencies to...more
On March 1, 2021, the Eurasian Patent Office (EAPO) launched the EAPO Pharmaceutical Register (the 'Register'). The Register lists Eurasian patents that relate to the active pharmaceutical ingredients of the drugs according...more
The COVID-19 pandemic has impacted every industry, causing global economic changes and, consequently, extensive legislative amendments. There are no doubts that the pharmaceutical industry is the most affected. Since the...more
On March 30, 2020, Russian pharmaceutical company, Biocad, announced that it and its partner, ICM d.o.o., recently obtained European registration certification in Bosnia and Herzegovina for two cancer treatment biosimilars: ...more
Below we list the measures introduced by Russian state authorities in response to and in connection with the COVID-19 pandemic. High Alert Regime - All regions of Russia, including Moscow and the Moscow Region, have...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
Under the Federal Law “On drugs circulation” (Law), information on state registration of drugs in Russia shall be publicly available. Pursuant to Art. 37(1) of the Law, MoH-s obligation is to disclose information regarding...more
Led by partner Natalia Gulyaeva, the Hogan Lovells Moscow team represented Novartis in a precedent case for pharma business proving that one can obtain an injunction using patent rights against a generic in Russia before the...more
U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more
Just when you were thinking things could not get any bigger after the Odebrecht/Braskem Foreign Corrupt Practices Act (FCPA) enforcement action, the Department of Justice (DOJ) and Securities and Exchange Commission (SEC)...more