DarshanTalks Podcast

Analyzing the Publication Rights Clause in CTAs

09 Sep 2024

Contributed by Lukas

Today's discussion revolves around the legal clauses found in clinical trials, with a focus on Article 8, the Publication Rights Clause.The foll...

What Really Starts Pharmacy Investigations?

07 Sep 2024

Contributed by Lukas

We discuss the seven ways pharmacy investigations can begin:1. Data Analysis: Agencies like the DEA and DOJ monitor prescription data for unusual patt...

Is your clinical trial AI racist?

20 Aug 2024

Contributed by Lukas

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 cl...

Another Pharmacy owner Jailed in Fraud Case

17 Aug 2024

Contributed by Lukas

Today we're diving into a critical issue that has shaken the pharmacy world. Recently, a pharmacy owner was sentenced for paying illegal kickback...

Navigating FDA's clinical trial expectations after approval

13 Aug 2024

Contributed by Lukas

Today, we're diving into the FDA's Fiscal Year 2022 report on postmarketing requirements (PMRs) and postmarketing commitments (PMCs). PMRs ...

Legal Minute: Do dietary supplements interact with drugs?

09 Aug 2024

Contributed by Lukas

Do dietary supplements interact with drugs? Many people think only prescription drugs can cause interactions, but dietary supplements can too. From an...

How Expert Pharma Marketers Navigate Privacy

07 Aug 2024

Contributed by Lukas

In today's consumer landscape, privacy concerns reign supreme. Pharmaceutical and medical device manufacturers must prioritize meeting the expect...

Hiring New Employees in PharmaTech Companies

02 Aug 2024

Contributed by Lukas

Edye Edens, a consultant and attorney with a background in regulatory affairs, shared insights into her unexpected yet exciting role at Weave, a rapid...

3 Hidden Dangers of Telehealth Marketing

29 Jul 2024

Contributed by Lukas

 In this episode, we discuss how drug and device manufacturers may seem to collaborate with telemedicine companies to market products and ensure pati...

Why a food lawyer would stop your restaurant’s marketing?

26 Jul 2024

Contributed by Lukas

Today, we're tackling a critical issue for restaurants and food marketers: promotional compliance and the risks of misbranding, as highlighted by...

Legal Minute: Why are there chemo drug shortages?

24 Jul 2024

Contributed by Lukas

We discuss how the shortage of chemotherapy drugs stems from economic challenges faced by generic drug manufacturers. Many cannot afford to produce th...

Are Pharma Giants Ignoring Clinical Trial Site Issues?

22 Jul 2024

Contributed by Lukas

In this episode, Daniel Fox discusses the key challenges faced by research sites, including trust issues, payment delays, and operational setbacks. He...

Why Adverse Events Go Unreported in Clinical Trials

18 Jul 2024

Contributed by Lukas

In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesita...

Who are patient advocates?

16 Jul 2024

Contributed by Lukas

In this episode, we delved into the pivotal role of patient advocates within the pharmaceutical industry. Patient advocates are champions who ensure t...

Why Drug Accountability Matters in Clinical Trials

11 Jul 2024

Contributed by Lukas

Drug accountability is a critical aspect monitored by the FDA at clinical trial sites. Principal investigators must maintain and document control over...

Legal Minute: What do I do if my med is on shortage?

09 Jul 2024

Contributed by Lukas

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...

5 reasons not to use AI in creating pharma marketing content

07 Jul 2024

Contributed by Lukas

We discuss the risks associated with using AI in your pharma marketing plans: 1.     Data Privacy and Security: Ensuring the security and privacy ...

8 essential elements of a valid prescription

06 Jul 2024

Contributed by Lukas

In this episode, we discussed eight essential strategies to prevent prescription drug fraud and abuse:Verify the prescriber's identity.Know the p...

No more lawyers in PRC?

04 Jul 2024

Contributed by Lukas

In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role...

Legal Minute: 4 Ways to Get Unapproved Drugs Legally!

02 Jul 2024

Contributed by Lukas

Today, we discuss four legal pathways to acquire unapproved drugs. First, over-the-counter drugs offer a route as some bypass FDA approvals, relying ...

The 4 Building Blocks of Using AI in any Pharma Marketing Strategy

27 Jun 2024

Contributed by Lukas

We discuss the essential elements to ensure that your pharma marketing plan aligns with AI use:1. Define Clear Goals: Establishing clear objectives is...

Legal Minute: Why Clinical Trials Are Right for You!

26 Jun 2024

Contributed by Lukas

In this short, we explore four key reasons to get involved in clinical research.First, it offers potential access to cutting-edge therapies, though it...

Why Clinical Researchers Are Flocking to MedSpas

24 Jun 2024

Contributed by Lukas

In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee .Darshan and Andrew discuss MedSpas. MedSpa...

Legal Minute: Why You Should Never Trust a Celebrity with Your Health

18 Jun 2024

Contributed by Lukas

Darshan explains  why you shouldn’t Trust Celebrities When Choosing Your Drugs!Hidden Agendas: They're paid to promote, not give unbiased advi...

Essential tips for pharmacy shutdowns

16 Jun 2024

Contributed by Lukas

Recent pharmacy walkouts and closures at major chains highlight a critical issue: staffing shortages. Independent pharmacies are also at risk. Here a...

Why Clinical Researchers Are Flocking to MedSpas

14 Jun 2024

Contributed by Lukas

In today’s episode, our guest is Andrew Stein, a partner in the healthcare department at Stevens and Lee.Darshan and Andrew discuss MedSpas. MedSpas...

Legal Minute: 5 Surprising Benefits of Ozempic!

11 Jun 2024

Contributed by Lukas

We dive deep into 5 uses of  Ozempic, a drug known for managing diabetes, but with surprising potential beyond! Here are 5 intriguing uses you might ...

Who Owns AI Generated Content in Pharma?

08 Jun 2024

Contributed by Lukas

In today's episode, we discuss AI-generated content in the pharmaceutical industry. AI has revolutionized content creation, but it's not wit...

Legal Minute: Why does my drug cost so much?

07 Jun 2024

Contributed by Lukas

In today’s short, Darshan discusses why drugs cost so much. It takes around 10 to 15 years and roughly $2.3 billion to bring a drug to market. That ...

AI for Promotions in FDA-Regulated Industries

06 Jun 2024

Contributed by Lukas

Join Darshan Kulkarni, a Food and Drug attorney, as he explores the dynamic intersection of artificial intelligence, drug and device promotion, and th...

Legal Minute: Billion-Dollar Speaker Scheme!

05 Jun 2024

Contributed by Lukas

Speaker programs are events sponsored by drug and device companies where a physician or other healthcare professional (HCP) delivers a speech or prese...

Off-Label Risks: Compliance Matters Now More Than Ever

03 Jun 2024

Contributed by Lukas

We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.We discuss the following:What does ...

6 Must-Knows Before Buying a Drug or Device Company

30 May 2024

Contributed by Lukas

Buying a Drug or Device Company? 6 Compliance Must-KnowsThinking of acquiring a drug or device company? Buckle up! This deal requires serious complian...

Legal Minute: Are there chemo drug shortages?

28 May 2024

Contributed by Lukas

We discuss how recent shortages of chemotherapy drugs like cisplatin and carboplatin have caused delays and changes in treatment plans for some cancer...

Legal Minute: Don’t Ignore State Registrations

24 May 2024

Contributed by Lukas

We discuss how failure to register with the appropriate state boards of Pharmacy as a drug or device manufacturer can lead to severe consequences. The...

Legal Minute: 6 Crucial Mistakes in Informed Consent

20 May 2024

Contributed by Lukas

We discuss six critical errors in the informed consent process:1. Exclusion of Principal Investigator: PI was not allowed to engage in the informed co...

Legal Minute: What is informed consent in clinical trials?

16 May 2024

Contributed by Lukas

Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of par...

Stop Risky Ads: Class Actions Could Cost You

13 May 2024

Contributed by Lukas

In this podcast, we discuss the following: Recent updates from the courts in class action lawsuits. Difference between equity and law. Demerging or...

Legal Minute: How do drugs work?

08 May 2024

Contributed by Lukas

Darshan explains that drugs work by either enhancing or inhibiting processes that already occur in the body. Put simply, they amplify or reduce the bo...

5 Surprising Causes of Life Science Deal Failures

03 May 2024

Contributed by Lukas

We discuss the five common reasons behind the failure of mergers, acquisitions and licensing deals  in the life sciences industry. Inadequate unders...

Legal Minute: Is pharma bribing your doctor?

29 Apr 2024

Contributed by Lukas

In this short, Darshan sheds light on the relationship between doctors and pharmaceutical companies. He explains how pharmaceutical companies often pa...

Legal Minute: Drug Registrations that can’t be ignored

23 Apr 2024

Contributed by Lukas

When acquiring a drug or device company, regulatory attorneys play a crucial role in ensuring compliance during the due diligence process. It's v...

Legal Minute: Why do pharmacies take so long to fill prescriptions?

19 Apr 2024

Contributed by Lukas

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. ...

Legal Minute: 3 Steps to Avoid Food Recalls

15 Apr 2024

Contributed by Lukas

We cover three steps for preventing food recalls:Identify all potential hazards.Focus on known and foreseeable risks.Develop preventive controls for s...

Legal Minute: Are dietary supplements as good as drugs?

12 Apr 2024

Contributed by Lukas

In this video, Darshan distinguishes between dietary supplements and drugs. The primary difference lies in the claims they can make. Dietary suppleme...

Legal Minute: Clinical Trial Record Retention Disasters

08 Apr 2024

Contributed by Lukas

Here are 5 clinical trial record retention problems.1. Fabricating Data and Documentation,2. Forging the Principal Investigator's signatures,3. D...

Legal Minute: Why is your medicine so expensive?

04 Apr 2024

Contributed by Lukas

Bringing a drug to market is a costly and intricate process, averaging $2.3 billion. This expense encompasses multiple levels of testing, ranging from...

McKinsey’s 2030 vision: A challenge for medical affairs

01 Apr 2024

Contributed by Lukas

McKinsey’s vision for Medical Affairs in 2030 envisions profound integration of digital tools, analytical innovation, evidence generation, and leade...

Legal Minute: 3 must-do takeaways for collecting diversity data in clinical trials

29 Mar 2024

Contributed by Lukas

In an ideal world, every patient in clinical trials would feel truly represented. In this video, Darshan Kulkarni outlines three crucial takeaways for...

Legal Minute: Are Brand and Generic Drugs Truly Different?

23 Mar 2024

Contributed by Lukas

We explore the chemical similarities and key differences between brand-name and generic drugs. Learn about:Equivalence in active ingredients, as appro...

Legal Minute: Who's REALLY Responsible for a Clinical Trial Congruency review?

18 Mar 2024

Contributed by Lukas

In this short, we discuss who is responsible for a congruency review in clinical trials. Our guest Istvan Fekete emphasizes that both pharmaceutical c...

This Drug Ad is FULL of Red Flags (We Expose Them All!)

13 Mar 2024

Contributed by Lukas

Today, we analyze a fictional drug advertisement, identifying and highlighting the nine key unethical and non-compliant elements.- Misleading Informat...

7 ways to challenge FDA’s regulation of LDTs

09 Mar 2024

Contributed by Lukas

The FDA's announcement of its intention to regulate Lab Developed Tests (LDTs) in line with medical device regulations has sparked concerns among...

Legal Minute: eBay’s $59 Million Drug-Making Problem

06 Mar 2024

Contributed by Lukas

eBay found itself as an unexpected marketplace for pill-making equipment, resulting in the company paying a hefty $59 million for facilitating the sal...

Legal Minute: Neuralink is a Game-Changer: 3 Lessons You Can't Afford to Miss

02 Mar 2024

Contributed by Lukas

In a recent announcement, Elon Musk's company Neuralink revealed the successful implantation of a brain device in a human, pushing the boundaries...

Legal Minute: Off-label marketing not ok again?

27 Feb 2024

Contributed by Lukas

In the US v. Facteau case, a recent development adds complexity to the FDA's ongoing struggle with off-label communications, particularly in ligh...

Don't Become the Next Fraud Headline: Lawyer Reveals Compliance Traps

25 Feb 2024

Contributed by Lukas

We discuss biotech fraud and the pivotal role of a comprehensive legal strategy, especially one that integrates FDA regulatory lawyers. A biotech CEO&...

Legal Minute: 3 Insider Secrets for a Successful Medical Device Recall

19 Feb 2024

Contributed by Lukas

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

Key elements of a successful congruency review for clinical trial agreements

15 Feb 2024

Contributed by Lukas

In a congruency review, the primary objective is to ensure alignment across various elements in clinical research. The initial crucial step involves a...

Why Private Equity firms are betting big on clinical research sites

12 Feb 2024

Contributed by Lukas

We delve into the growing allure of clinical research sites and organizations for private equity firms. Backed by BPOC, these investments signify more...

5 Ways to Legally Share Off-Label Information

07 Feb 2024

Contributed by Lukas

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...

DOJ's "Get Out of Jail Free" card for pharma and device mergers?

04 Feb 2024

Contributed by Lukas

Darshan discussed crucial updates to the Department of Justice's (DOJ) corporate enforcement policies, particularly impacting FDA-regulated indus...

Legal Minute: 5 factors to get your digital speaker program approved

01 Feb 2024

Contributed by Lukas

In this podcast, we discuss the legal and regulatory factors for securing approval for your digital speaker program. Key points include prioritizing ...

Legal Minute: Decoding the FDA's prescription drug use related software guidance

30 Jan 2024

Contributed by Lukas

FDA Issues Crucial Guidance on Prescription Drug Software! Darshan Kulkarni delves into the FDA's recent guidance on prescription drug-related s...

Congruency Review: The Game Changer

28 Jan 2024

Contributed by Lukas

Insider Exposes crucial missing step in Clinical Trial Agreements activation - Congruency Review Details Revealed!In the clinical trial agreement acti...

Legal Minute: 5 hacks to fast-track your speaker program reviews

24 Jan 2024

Contributed by Lukas

Accelerate your digital speaker program review with these 5 game-changing strategies: Policy Creation & Training Pre-reviews AI-based Reviews ...

Selecting your ideal subject recruitment partner

22 Jan 2024

Contributed by Lukas

Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company'...

Your digital sales team’s success depends on these 5 compliance rules

19 Jan 2024

Contributed by Lukas

We discuss five key legal and regulatory considerations for a digital sales force: Starting with updates to the Physician Payment Sunshine Act, emphas...

Legal Minute: 3 FTC rules for winning comparative claims

16 Jan 2024

Contributed by Lukas

We explore the crucial aspects outlined by the FTC regarding comparative claims in drug and device advertising. the paramount importance of transpare...

The risks and rewards of Clinical Research as a Care Option

14 Jan 2024

Contributed by Lukas

In this podcast, we explore a groundbreaking shift where clinical research is emerging as a viable care option, known as Clinical Research as a Care O...

3 game changing ways the FDA says AI will transform drug development

11 Jan 2024

Contributed by Lukas

In this podcast, we discuss artificial intelligence (AI) and machine learning, exploring their pivotal roles in drug development. AI, a fusion of comp...

Legal Minute: Comparative claim review by NAD

10 Jan 2024

Contributed by Lukas

The National Advertising Division (NAD) recently examined a TV ad by Bravecto, comparing its flea and tick prevention product with NexGard's. The...

5 foolproof ways to get your digital speaker program approved

05 Jan 2024

Contributed by Lukas

In this podcast, five crucial considerations for obtaining approval for a digital speaker program are discussed:1. Privacy Compliance:   - Consider ...

Legal Minute: Prepare your Cosmetics Company for 2024

02 Jan 2024

Contributed by Lukas

he recently issued FDA guidance mandates manufacturers, packers, and distributors to adhere to new standards, emphasizing mandatory product and facili...

How to get PRC to approve your ads quickly

29 Dec 2023

Contributed by Lukas

In this podcast episode, we'll uncover five strategies to expedite the digital promotion review process. Starting with1. Policy creation and trai...

Legal Minute: 4 Must Do's When Choosing a Predicate Device for Your 510(k)

21 Dec 2023

Contributed by Lukas

Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices fo...

Legal Minute: FDA's Vision for the Future of IT

14 Dec 2023

Contributed by Lukas

Darshan Kulkarni discusses the FDA's IT strategy for 2024 to 2027. The FDA aims to create a unified FDA ecosystem, promote cross-functional colla...

Legal Minute: FTC announces major revamp in 2024 enforcement strategy

10 Dec 2023

Contributed by Lukas

In a significant update on September 19th, Samuel Levine, Director of the #FTC's Bureau of Consumer Protection, outlined the agency's key pr...

23andMe data breach: Is your genetic data the next big target for hackers?

07 Dec 2023

Contributed by Lukas

This week, a data breach was disclosed by 23andMe, affecting 6.9 million users and compromising their genetic data information. The incident raises si...

Ultimate Guide for Clinical Trial Publishing Rights in Large Academic Centers | Istvan Fekete

06 Dec 2023

Contributed by Lukas

Guest Istvan Fekete discusses what large academic medical institutions are responsible for that sponsors and other commercial entities are generally n...

FDA's off-label trap: 7 reasons for uncertainty

04 Dec 2023

Contributed by Lukas

In this video,, the focus is on the growing interest in digital engagement programs among FDA-regulated companies, but it also addresses the concerns ...

Legal Minute: 3 ways #pharmacies are fighting high generic drug prices!

01 Dec 2023

Contributed by Lukas

Darshan Kulkarni talks about how the generic drug industry is facing several challenges that are impacting profitability, including:1. Pressure from i...

Pharma Industry Secrets: The Surprising Truth About DEI | Celia Daniels

24 Nov 2023

Contributed by Lukas

Recently, Celia Sandhya Daniels was announced to be one of the top 20 LGBTQ leaders in Bio Pharma by Endpoints News.In this episode, We're ventur...

Case Study: Academic Research Center Misconduct

15 Nov 2023

Contributed by Lukas

The case study on academic research center misconduct highlights the urgency to address and prevent such issues in the field. Instances of research mi...

Legal Minute: FTC Cracking Down on AI- 3 Must-Know Tips to Stay Compliant

11 Nov 2023

Contributed by Lukas

Planning to incorporate artificial intelligence into your business in 2024? Stay informed about the Federal Trade Commission's (FTC) expectations...

Project management as a clinical research game-changer

05 Nov 2023

Contributed by Lukas

Jessica Thompson discusses how project management can be a game-changer in clinical research.  We talk about how poor project management can lead to ...

Legal Minute: 5 Must-Do’s for Virginia Tech’s FBRI to combat research fraud

31 Oct 2023

Contributed by Lukas

Virginia Tech recently received a $50 million gift from the Red Gates Foundation for Health Sciences research expansion. In light of recent news about...

Legal Minute: Pharmacy Closing Checklist: 7 Must Do's

26 Oct 2023

Contributed by Lukas

We discuss the 7 things to do before closing your pharmacy:1. Return your DEA registration,2. Notify the Board of Pharmacy,3. Dispose of controlled su...

FDA Approval for LDTs Made Easy

22 Oct 2023

Contributed by Lukas

The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensu...

Legal Minute: Pharmacist fraudster found guilty

19 Oct 2023

Contributed by Lukas

On September 5th, 2023, a Miami jury found a medical clinic owner and pharmacist guilty of falsifying and fabricating clinical trial data. We highlig...

AI's Complex Role: Creator, Copycat or Both?

15 Oct 2023

Contributed by Lukas

In this episode, guest Dave Bulger delves into the intricate role of AI, questioning whether it functions as a creator, a copycat, or perhaps both. Da...

FDA warns 8 companies including Walgreens selling unapproved eye products

10 Oct 2023

Contributed by Lukas

The FDA has taken action by sending warning letters to eight companies that have been marketing unapproved eye products, potentially violating federal...

Why the FDA’s plan to use one pagers will fail

05 Oct 2023

Contributed by Lukas

FDA is suggesting the use of one-pagers to provide essential drug information to patients. Past attempts faced challenges, such as one-size-fits-all c...

Supercharge your Marketing Approval Process based on these Concept Review Tips

03 Oct 2023

Contributed by Lukas

 In this episode, we’ll discuss how to speed up your marketing approval process with these must know concept review tips. We will talk to Heather M...

Testosterone parties and unapproved biohacks: Is it worth the risk? #darshantalks

01 Oct 2023

Contributed by Lukas

 We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices ra...

Generative AI…confidently spews BS!

30 Sep 2023

Contributed by Lukas

 AI expert Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limita...

Testosterone parties and unapproved biohacks: Is it worth the risk? #darshantalks

28 Sep 2023

Contributed by Lukas

 We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices ra...

Research Fraudster Banned by the FDA

28 Sep 2023

Contributed by Lukas

 Mayya Tatsene has been issued a final debarment order by the FDA. The reason for the debarment stems from violating FDA regulations concerning clini...

How does CTP regulate tobacco? | Micah Berman

26 Sep 2023

Contributed by Lukas

 The FDA's Center for Tobacco Products (CTP) was created in 2009 to regulate tobacco products. Micah Berman worked at CTP from 2011-2012. He dis...

60 second reveal: 3 Regulatory authorities that can make or break your pharma or device sale

24 Sep 2023

Contributed by Lukas

 Darshan Kulkarni emphasizes that companies considering #acquisitions must be ready for scrutiny from multiple agencies: FDA, FTC, DOJ, and OIG. FDA ...