DarshanTalks Podcast

When selling a company, certain issues may arise that could concern potential buyers. Here's a breakdown of how to approach them:

1. Price Adjustments: Some issues can be acknowledged, and the buyer may …

Darshan Kulkarni and Edye Edens discuss the latest update to Good Clinical Practice (GCP) guidelines, E6 R3, was explored. GCP, developed by the International Council for Harmonisation (ICH), provide…

Artificial intelligence (AI) is rapidly reshaping healthcare, with over 950 FDA-authorized AI devices transforming diagnosis, treatment, and administrative workflows. AdvaMed's new position paper emp…

Teva Pharmaceutical's $450 million settlement highlights the challenges of compliance in the pharmaceutical industry. The Department of Justice accused Teva of violating the anti-kickback statute and…

Today, we explore a pressing issue in the healthcare landscape: the liability associated with artificial intelligence (AI). As AI technologies transform healthcare—from diagnostic tools to treatment …

Grant fraud encompasses four critical issues that can have severe repercussions for institutions and individuals.
1. Foreign Influence and Funding:

• Failing to disclose foreign government support, as se…

When conducting due diligence for a life sciences company, it's essential to align the scope with the transaction's objectives. Key considerations include:

• Transaction Purpose: Determine if the goal i…

Darshan Kulkarni and Edye Edens discuss the essential steps for launching a clinical trial site, emphasizing the importance of navigating both state-specific regulations and the logistics involved. T…

Misinformation around vaccines and treatments isn’t new, but with figures like Robert F. Kennedy Jr. in the spotlight, how should regulatory agencies respond?

There will be potential changes coming to…

When preparing to sell your pharmaceutical company, particularly with a Phase 1 product, it’s essential to assess potential buyers and ensure readiness. 

Darshan’s Insights:
 When preparing to sell you…

Launching a clinical trial site is an exciting opportunity, but it comes with important legal, regulatory, and operational challenges.

Darshan Kulkarni Says:
 Starting a clinical trial site is an excit…

Darshan reacts to a fake interaction between a drug sales representative and a doctor. He shares insights on pharmaceutical marketing tactics, highlighting that while doctors often find sales reps pe…

Pharmaceutical companies, like Pfizer, are venturing into digital healthcare platforms, raising questions about competition with traditional pharmacies. Pfizer recently announced its initiative, "Pfi…

In this episode, guest host Kate Woods interviews Jessica Miller, who shares her journey with functional medicine, highlighting its focus on addressing root causes of illness through personalized, li…

Grant fraud encompasses four critical issues that can have severe repercussions for institutions and individuals:

1. Foreign Influence and Funding:

• Failing to disclose foreign government support, as seen …

In this episode, Darshan explores how artificial intelligence (AI) is transforming clinical trial design, with a focus on using real-world data (RWD). The episode dives into the FDA’s recognition of …

The FDA’s 2024 guidance on decentralized clinical trials (DCTs) has the potential to transform clinical research, particularly in oncology. While many still view DCTs as either fully virtual or fully…

The stem cell industry is growing rapidly but faces heightened regulatory scrutiny, particularly regarding marketing practices. Recent events highlight this issue: Rebecca Tushnet's blog on state "Li…

In this episode, Darshan reacts to how at the start of each year, pharmacists often face the challenge of informing patients that their medications are no longer covered due to formulary changes mana…

Rebecca Tushnet discusses the potential explores the implications of misleading advertisements, particularly concerning pregnancy clinics. Even true statements can be disparaging if they mislead cons…