DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
Episodes
109 episodes
AI Data Ownership in Pharma
we explore how AI is transforming content generation in the pharmaceutical industry, particularly in marketing, sales, and medical engagements. While AI presents groundbreaking opportunities, it also raises critical challenges, notably concerni...
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4:59
Role of Tech Transfer in Clinical trial agreements
In this episode, we are joined by Istvan Fekete to have a discussion over tech transfer offices, IP, and more. The video explains what tech transfer offices are, their significance in the research ecosystem, and why they might be the best pl...
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7:30
Why are medicine names so complicated?
Darshan was asked to explain why drug names can be so complicated, and the answer lies in the fact that each drug typically has at least three distinct names. First, there’s the chemical name, which is a technical identifier describing the d...
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2:09
Fixing Congruency Reviews in 8 Minutes
In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounter during these reviews and examine effective strategies for handling these errors. Addition...
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8:36
The Dark Side of Med Device Kickbacks
Today, we're discussing a critical issue for pharmaceutical and medical device marketers – promotional compliance.Overview of the Innovasis Settlement:Innovasis Inc. recently settled a $12 million case for alleged...
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4:45
Which Hair Loss Treatment Is Right for You?
Darshan addresses common questions about potential treatments for hair loss. He provides insights based on his expertise as both a pharmacist and an FDA regulatory lawyer.Darshan explains that FDA-approved treatments for hair l...
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2:29
Analyzing the Publication Rights Clause in CTAs
Today's discussion revolves around the legal clauses found in clinical trials, with a focus on Article 8, the Publication Rights Clause.The following points are discussed:Unrestr...
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1:49
What Really Starts Pharmacy Investigations?
We discuss the seven ways pharmacy investigations can begin:1. Data Analysis: Agencies like the DEA and DOJ monitor prescription data for unusual patterns, such as excessive dispensing of certain drugs.2. Tips: An...
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1:52
Is your clinical trial AI racist?
We dive into the critical issue of racial bias in AI, highlighted by a recent Yale study focusing on ChatGPT. This has significant implications for clinical research sponsors, sites, and principal investigators. We also explore the FDA's per...
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4:52
Another Pharmacy owner Jailed in Fraud Case
Today we're diving into a critical issue that has shaken the pharmacy world. Recently, a pharmacy owner was sentenced for paying illegal kickbacks and engaging in a money laundering conspiracy. This case has significant implications for promoti...
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3:04
Navigating FDA's clinical trial expectations after approval
Today, we're diving into the FDA's Fiscal Year 2022 report on postmarketing requirements (PMRs) and postmarketing commitments (PMCs). PMRs are mandatory studies required by the FDA after a drug's approval, focusing on real...
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3:25
Legal Minute: Do dietary supplements interact with drugs?
Do dietary supplements interact with drugs? Many people think only prescription drugs can cause interactions, but dietary supplements can too. From an FDA perspective, a drug is defined by its claims and indications. Some supplements make dr...
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0:59
How Expert Pharma Marketers Navigate Privacy
In today's consumer landscape, privacy concerns reign supreme. Pharmaceutical and medical device manufacturers must prioritize meeting the expectations of this privacy-conscious generation. This begins with three key measures:...
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1:26
Hiring New Employees in PharmaTech Companies
Edye Edens, a consultant and attorney with a background in regulatory affairs, shared insights into her unexpected yet exciting role at Weave, a rapidly growing startup specializing in AI-driven solutions for regulatory content creation. Edye d...
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22:05
3 Hidden Dangers of Telehealth Marketing
In this episode, we discuss how drug and device manufacturers may seem to collaborate with telemedicine companies to market products and ensure patient needs are met conveniently. However, there are three major concerns:1...
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1:51
Why a food lawyer would stop your restaurant’s marketing?
Today, we're tackling a critical issue for restaurants and food marketers: promotional compliance and the risks of misbranding, as highlighted by a recent case in Biloxi. Mary Mahoney's Old French House Restaurant and its co-owner, Anthony C...
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1:38
Legal Minute: Why are there chemo drug shortages?
We discuss how the shortage of chemotherapy drugs stems from economic challenges faced by generic drug manufacturers. Many cannot afford to produce these drugs due to low profitability. Factors include factory shutdowns for quality issues, a co...
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0:52
Are Pharma Giants Ignoring Clinical Trial Site Issues?
In this episode, Daniel Fox discusses the key challenges faced by research sites, including trust issues, payment delays, and operational setbacks. He emphasizes initiatives like the "Open Mic" policy for anonymous feedback and the grassroots m...
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30:10
Why Adverse Events Go Unreported in Clinical Trials
In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesitate to report due to concerns about trial disruption, revenue loss, and increased scrutiny. ...
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1:51
Who are patient advocates?
In this episode, we delved into the pivotal role of patient advocates within the pharmaceutical industry. Patient advocates are champions who ensure that patients' voices are not only heard but also central to decisions affecting their healt...
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3:53
Why Drug Accountability Matters in Clinical Trials
Drug accountability is a critical aspect monitored by the FDA at clinical trial sites. Principal investigators must maintain and document control over investigational products, ensuring they are only administered under direct supervision. Cl...
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1:43
Legal Minute: What do I do if my med is on shortage?
We discuss how to address drug shortages. First things first, it's important to stay calm. Just because there's a shortage doesn't mean you'll lose access to your medication entirely. Here are some action steps you can take: 1. Sch...
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0:47
5 reasons not to use AI in creating pharma marketing content
We discuss the risks associated with using AI in your pharma marketing plans: 1. Data Privacy and Security: Ensuring the security and privacy of data, whether it pertains to patients or non-patients, is paramount....
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1:26