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
Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more
This report was written in partnership with and funded by the Foundation for Opioid Response Efforts. During the COVID-19 pandemic, the federal government and many states offered regulatory flexibilities intended to make...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
The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...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
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...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
(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
COMPETITION & STATE AID - Competition- European Commission ramps up home searches of employees of companies suspected of potential competition breaches - On 5 April 2022, Maria Jaspers (Director of Cartel Directorate, DG...more
COMPETITION & STATE AID- Competition- European Commission publishes 2021 General Report on Activities of the European Union - On 9 March 2022, the Commission published “The EU in 2021 – General Report on the Activities of...more
COMPETITION & STATE AID - State Aid- European Commission publishes Annual Single Market Report 2022 - On 22 February 2022, the European Commission published the Annual Single Market Report 2022, which sets out, in...more
COMPETITION & STATE AID - State Aid- Fit for Future Platform pursues simplification of EU law, including Opinion on State aid - On 28 January 2022, the Fit for Future Platform, a high-level expert group to assist the...more
Congress - The House is in a district work period this week. The Senate is in a state work period this week. Senate - Short-Term Continuing Resolution Passes Senate and is Signed by the President - On Feb. 18,...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
Competition - European Commission comments on the future of competition policy - On 29 October 2021, Executive Vice-President and Competition Commissioner Margrethe Vestager provided remarks on the future of competition...more
European Commission adopts Communication on Energy Prices to tackle exceptional rise in energy prices - On 13 October 2021, the Commission adopted a Communication on Tackling Rising Energy Prices: a Toolbox for Action and...more
State Aid - European Commission consults on proposed amendments to General Block Exemption Regulation - On 6 October 2021, the Commission opened its consultation with Member States and interested parties to comment on...more
European Commission releases State of the Union 2021 report, including on COVID-related State aid - On 15 September 2021, the Commission published the State of the Union 2021 report on the Commission’s work and...more
I. Introduction - Use and acceptance of telehealth technologies have grown very substantially since the start of the COVID-19 pandemic. This growth has been substantially facilitated by waivers and relaxations of existing...more
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS...more
The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more