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 Thursday, June 13, the Supreme Court of the United States issued three decisions: FDA v. Alliance for Hippocratic Medicine, No. 23-235: This case involves an attempt to rescind the Food and Drug Administration’s...more
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more
Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more
Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more
On November 17, 2022, the Court of Justice of the European Union (CJEU) found in its latest principal judgment (Novartis v. Abacus, case file C-147/20) that the reboxing of parallel imported medicines in the European Union...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
Examining attorneys at the U.S. Patent and Trademark Office (USPTO) are citing a recent 2020 decision by the Trademark Trial and Appeal Board (TTAB) to support the position that trademarks for many products (particularly...more
As of June 16, 2020, the U.S. Patent and Trademark Office has implemented a program to prioritize the examination of trademark applications that cover goods and services that help prevent, diagnose, treat, or cure COVID-19....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
The process of developing and bringing a drug to market is long and expensive, and from test tube to pharmacy, the competition for resources – including clinical trial participant and investor resources – is fierce. To...more
Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more
In Canada, trademarks for pharmaceutical preparations and related products have faced numerous challenges, some of which are unique to the industry. This article will canvas the current issues as well as the important changes...more
Recently, the Canada Border Services Agency (CBSA), the federal organization responsible for policing Canada’s borders, issued a Customs Notice (CN17-27) to advise the public and rights holders that its 24/7 “Border Watch”...more
While the concept of “fake news” continues to trigger Twitter followers and grab headlines, the trade in counterfeit drugs is a worldwide problem of significant scale. This article discusses the problem and talks about some...more
Each month, Nexsen Pruet attorney Marc Manos, a member of the SC Bar Torts and Insurance Practice Section Council, sheds light on a few recent cases from the Fourth Circuit Court of Appeals, focused in the area of Torts &...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more
Alien Tort Statute (ATS)/Torture Victims Protection Act (TVPA)/Anti-Terrorism Act (ATA) - District Court Dismisses ATS Claim Where Alleged Conduct in US Was Not Directly Linked to Injuries Claimed in Other Countries - ...more
The Food and Drug Administration (FDA) has finalized guidance for industry describing the agency’s evaluation process for proposed proprietary names for drug and biological products. The guidance applies to all prescription...more
In late May, the FDA released a draft guidance document detailing its best practices for developing trademarks for drugs. The draft guidance, entitled Best Practices in Developing Proprietary Names for Drugs, can be found...more
In This Issue: - FDA Draft Guidance: Best Practices for Developing Drug Trademarks - U.S. Patent and Trademark Office Proposes Fee Reductions - gTLD Sunrise Periods Now Open - Excerpt from U.S. Patent and...more
In an interesting precedential decision, the Trademark Trial and Appeal Board (TTAB) canceled a registration for FLANAX despite the fact that the petitioner, Bayer Consumer Care AG, did not use FLANAX in the United States,...more
“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the...more
An interesting debate recently occurred in the New England Journal of Medicine between a physician and the U.S. Food and Drug Administration (FDA) regarding whether the letters X and Z are used too frequently in...more