Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
On December 27, President Biden signed the Preventing Organizational Conflicts of Interest in Federal Acquisition Act into law. The legislation, ushered through Congress by a bipartisan group of backers, strengthens existing...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
Billions of dollars have flown from medical device makers to specialists performing back, spine, knee, and hip surgeries, with unsavory cash and practices also accompanying that fiscal tide. Industry officials and...more
With $2 billion on the line, the highest court in the nation has refused to hear an appeal that aimed to undo a jury award given to cancer patients and their families....more
Although Big Pharma has taken deserved heat for selling its drugs by slathering doctors with cheesy tchotchkes, lavish or even cheap meals, and pricey trips, as well as lucrative consulting and speaking opportunities, medical...more
On July 8, 2020, Judge Alison Burroughs granted-in-part Defendants Shire and Actavis’s motion to decertify a direct purchaser plaintiff class in an alleged reverse payment antitrust case pending in the Federal District Court...more
Elite researchers — professors and staff with ties to 20 of the nation’s top universities and the respected National Institutes of Health — may be failing to be as candid as institutions and laws require about their potential...more
In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA)...more
Tip #2: Thorny Issues with Commissions Part 1: What Happens When a Salesperson Is Selling a Drug To Herself or Her Family Member? A key component of compensation for pharmaceutical salespeople is the sales commission, and...more
OxyContin-maker Purdue Pharma and its owners, the Sackler family, reached a deal this week with the state of Oklahoma in which they will pay “$270 million to avoid going to a state court trial over the company’s role in the...more
This decision of the Federal Circuit in Dr. Falk Pharma GmbH v. GeneriCo, LLC involves disqualification due to conflict of interest of counsel representing Mylan Pharmaceuticals in three separate appeals. As set forth in the...more
Media coverage of diet and nutrition topics, for their abundance of hype and sheer bunk, may take the cake. Some recent, solid reports not only offer examples of the scope and scale of this public tomfoolery and its costs but...more
Brenda Fitzgerald, a rich doctor who not only wouldn’t pull her hand out of her personal cookie jar of investments and instead plunged it even deeper during her conflicted time in public office, finally has quit the top job...more
In a prior blog post from September 8, 2017, we wrote about the many ways in which states are addressing the opioid crisis through legislation. One of the states we discussed was New Jersey who at the time had proposed a new...more
The Maine legislature passed with broad bipartisan approval L.D. 911, An Act to Prohibit Certain Gifts to Health Care Practitioners. The legislation prohibits gifts to practitioners who are licensed to prescribe and...more
The U.S. Congress, based on its members’ legally required financial disclosures, fares far better than most. Senators and representatives are worth a net $1 million on average. But is it seemly for so many of our crucial...more
At a time when drug costs are skyrocketing and Americans are demanding relief, President Trump’s nominee to be the chief regulator of Big Pharma and medical device makers says he initially must sidestep a lot of oversight of...more
It’s a $50-million business with a roster of blue-chip consultants who would be an envied faculty at most any major university. But look closely at the activities of Precision Health Economics because this firm’s esteemed...more
This month Richard Zall, Chair of Proskauer's Health Care Department, explores developments likely to occur with respect to the Affordable Care Act as a result of the new administration. In our Rulings, Filings and...more
The numbers are small but the implications significant. A pair of academic researchers has tossed a conflict-of-interest grenade in the laps of the leaders of the federal Food and Drug Administration. Is there too much of a...more
On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more
In This Issue: - Is There a Problem? Let Us Count the Ways - A Growing Awareness - Getting Objective Information - Recent Health Care News You Should Know About - Excerpt from Navigating Through Medical...more