Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
A March 21 Federal Circuit decision in Actavis Laboratories FL, Inc. v. United States, No. 23-1320 (Fed. Cir. Mar. 21, 2025) marked a victory for generic drug developers, affirming that legal expenses incurred defending...more
Tax developments - Actavis and deductible expenses - On March 21, 2025, the Court of Appeals for the Federal Circuit released a decision in Actavis Laboratories FL, Inc. v. United States, holding that taxpayers could...more
On March 21, the Court of Appeals for the Federal Circuit held in a precedential opinion that legal fees incurred by generic drug companies in defending against patent infringement suits brought under the Hatch-Waxman Act...more
President Donald Trump has issued a presidential memorandum, which has the effect of an Executive Order, titled “Regulatory Freeze Pending Review“ (the Regulatory Freeze). This Regulatory Freeze puts a hold on new agency...more
On January 13, the chief administrative law judge of the US Drug Enforcement Administration (DEA), John Mulrooney, postponed the highly anticipated hearing on the rescheduling of cannabis under the Controlled Substances Act...more
For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more
On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more
Well, Easter has come, which can only mean that it is time for our spring holiday compliance special! In honor of the season, here are some interesting facts about Beatrix Potter, the author of The Tale of Peter Rabbit: ...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
In an opinion released July 27, 2023, the Third Circuit affirmed a 2021 Tax Court decision upholding a pharmaceutical company’s immediate deduction of patent defense litigation costs in suits brought under the Hatch-Waxman...more
Outlook for This Week in the Nation’s Capital - Congress. Congress is in recess this week. Shortly after returning from the midterm election break, both parties will hold votes on their leadership. House Speaker Nancy Pelosi...more
We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 covers year-end health and welfare plan issues....more
Outlook for This Week in the Nation’s Capital - Congress. The House and Senate are both in recess until Labor Day. Once they return, they will have a packed to-do list ahead of the November elections, which may include...more
LIBOR Relief Included In Appropriations Bill - New York Law Concerns - The New York law enacted in April 2021 provides the ‘Get Out of Jail’ card[2] for banks from litigation relating to the LIBOR (London InterBank...more
Whether the United States Patent and Trademark Office (USPTO) possessed trademark registrations for its own trademarks was honestly not something I had ever thought about before. But then I received a link to the Director’s...more
Under the Internal Revenue Code (“Code”) Section 162, ordinary and necessary business expenses are deductible, but Code Section 263 disallows a deduction for capital expenditures (“no deduction shall be allowed” for a capital...more
On April 27, 2021, the United States Tax Court held that legal fees incurred by generic drug manufacturers in connection with “Section 271(e)(2)” patent infringement suits are deductible as ordinary business expenses and need...more
In Washington: President Biden on Tuesday began what is expected to be a weeks-long sales pitch to tout the new coronavirus relief package. Biden visited Smith Flooring in Chester, Pennsylvania, a small business that received...more
DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008 - On January 14, 2021, the Department of Justice (DOJ) announced that it obtained more than $2.2 billion in settlements and judgments from civil cases involving...more
In Washington: Sen. Chuck Grassley (R-IA) said on Tuesday that he would quarantine after exposure to COVID-19. Grassley added that he was "feeling well" and asymptomatic but that "it’s important we all follow public health...more
In Washington: The Senate Appropriations Committee on Tuesday released drafts of all 12 annual spending bills for 2021, setting up negotiations for a deal ahead of the Dec. 11 deadline to keep the government-funded. Bogged...more
In Washington: After several consecutive days of talks between House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin it appears increasingly likely that Congress will have to wait to consider any COVID-19...more
In Washington: President Trump said Thursday that he is willing to go higher than his current $1.8 trillion offer for the next coronavirus stimulus package as negotiations continue. “Go big or go home,” Trump told Fox...more
Below, please find a summary of recent federal government activity in response to the COVID-19 pandemic. Congress - On Tuesday, after returning from the August recess, Senate Republicans unveiled a “targeted” COVID...more
Congress - Congressional leaders from both parties and administration officials have acknowledged that the two sides remain far apart as negotiations on the next COVID relief package continue....more