DarshanTalks Podcast

Have you ever wondered why your prescription takes what feels like an eternity to fill at the pharmacy? Darshan will shed some light on the process. 

When you drop off your prescription, the pharmacist isn't just mindlessly grabbing bottles from shelves. They're meticulously reviewing your medication to ensure it's the right fit for your condition, checking for potential interactions with other drugs or even...

In this video, Darshan distinguishes between dietary supplements and drugs. The 
primary difference lies in the claims they can make. Dietary supplements are treated as foods and can only make limited claims, such as improving health or well-being. In contrast, drugs undergo rigorous FDA approvals and trials to make claims of curing, treating, preventing, or mitigating diseases. While there may not be much difference chemically...

Here are 5 clinical trial record retention problems.
1. Fabricating Data and Documentation,
2. Forging the Principal Investigator's signatures,
3. Data Manipulation,
4. Misappropriating Samples and 
5. Forging Subject Dairies

Join us as we delve into the complexities of record retention and data integrity in clinical trials. Learn why compliance is key for FDA approval and how we can help. Call us ...

Bringing a drug to market is a costly and intricate process, averaging $2.3 billion. This expense encompasses multiple levels of testing, ranging from small animals to extensive human trials. The drug company, whether partnering with a university or a private investor, foots the bill for each phase of testing, ensuring safety and efficacy before reaching the market. The investment covers meticulous testing procedures, safeguarding ...

McKinsey’s vision for Medical Affairs in 2030 envisions profound integration of digital tools, analytical innovation, evidence generation, and leadership transformation. However, this vision faces a critical challenge as recent lawsuit losses against the FDA have shifted the landscape. Previously, Medical Affairs held the exclusive right to share off-label information, but FDA losses prompted guidelines allowing sales reps, under s...

In an ideal world, every patient in clinical trials would feel truly represented. In this video, Darshan Kulkarni outlines three crucial takeaways for collecting diversity data in clinical trials, following guidelines from the FDA.
 The guidance emphasizes that one size does not fit all when it comes to race and ethnicity, encouraging detailed categories to embrace the global diversity of participants. 
Darshan advises star...

In this short, we discuss who is responsible for a congruency review in clinical trials. Our guest Istvan Fekete emphasizes that both pharmaceutical companies and research sites share the responsibility for ensuring congruency between the budget, contract, informed consent form (ICF), and coverage analysis. Istvan mentions that a lack of congruency affects both parties and, therefore, both sides should actively participate in the v...

Today, we analyze a fictional drug advertisement, identifying and highlighting the nine key unethical and non-compliant elements.
- Misleading Information: The claim "The End of High Blood Pressure" suggests that the drug can completely cure high blood pressure, which is likely exaggerated and misleading.
2- Absolute Efficacy Claims: Stating "Proven to work in 100% of patients" is an absolute claim that ...

The FDA's announcement of its intention to regulate Lab Developed Tests (LDTs) in line with medical device regulations has sparked concerns among developers, anticipating significant financial implications. 
We provide a comprehensive overview of seven strategic approaches for LDT developers to challenge the FDA's regulatory proposal. 
Firstly, leveraging the public comment period,
Participating in Part 15 hea...

eBay found itself as an unexpected marketplace for pill-making equipment, resulting in the company paying a hefty $59 million for facilitating the sale of such equipment. In our video, Darshan delves into this crackdown, shedding light on the hidden underbelly of online retail. The incident highlights the ease with which tools for potentially illegal drug manufacturing can evade e-commerce oversight. He emphasizes the importance of...

In a recent announcement, Elon Musk's company Neuralink revealed the successful implantation of a brain device in a human, pushing the boundaries of neurotechnology.
 In our latest short, we discuss key considerations for those venturing into such groundbreaking work. 
We emphasize the importance of having a clear investigational plan that outlines study design, methodologies, endpoints, and analysis strategies. 
A...

In the US v. Facteau case, a recent development adds complexity to the FDA's ongoing struggle with off-label communications, particularly in light of the SIUU guidance and the CFL guidance. The First Circuit ruled against Facteau, emphasizing the distinction from the Caronia case. Unlike Coronia, where the focus was on broader free speech and off-label promotion issues, the US v. Facteau case centered on the roles and actions ...

We discuss biotech fraud and the pivotal role of a comprehensive legal strategy, especially one that integrates FDA regulatory lawyers. A biotech CEO's admission to securities fraud, misleading investors about a crucial test, underscores the need for stringent legal oversight.

At the Kulkarni Law Firm:

We’re on the lookout for major red flags, 
We ensure press releases not only comply with SEC regulations...

In December 2023, two US senators raised concerns, urging the government to scrutinize the FDA's oversight of medical device recalls, notably amidst the ongoing Phillips Respironics recall.

Join us today as we delve into the world of medical device recalls. Facing a recall is every manufacturer's nightmare, but handling it right is paramount. It safeguards patients, preserves reputations, and sidesteps legal nigh...

In a congruency review, the primary objective is to ensure alignment across various elements in clinical research. The initial crucial step involves accurately analyzing Medicare coverage, determining designations based on National and Local Coverage Determinations. This forms the foundation for what is billed to the study sponsor and insurance. Any discrepancies at this stage can lead to downstream errors.

Following the c...

We delve into the growing allure of clinical research sites and organizations for private equity firms. Backed by BPOC, these investments signify more than just single business deals; they are a testament to the increasing interest in fueling healthcare innovation and services.

As this trend gains momentum, thorough due diligence becomes crucial in navigating the complexities of these acquisitions. The Kulkarni Law Firm, s...

In this episode, the focus is on navigating the complex landscape of off-label information sharing, exploring legal aspects in the context of the life sciences industry. Sponsored by the Kulkarni Law Firm, the episode highlights key points:

1. Scientific discussions: Courts are generally cautious about FDA scrutiny in scientific discussions, such as those in academic conferences or scholarly articles, falling within FDA sa...