Beste DarshanTalks podcaster (2024)

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6 Must-Knows Before Buying a Drug or Device Company 1:31

3d ago1:31

1:31

Buying a Drug or Device Company? 6 Compliance Must-Knows Thinking of acquiring a drug or device company? Buckle up! This deal requires serious compliance considerations. Here's a quick rundown: The DOJ offers a 6-month "safe harbor" for confessing past compliance issues. Use it! The DOJ demands strong compliance programs with thorough risk assessme…

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Legal Minute: Are there chemo drug shortages? 0:50

5d ago0:50

0:50

We discuss how recent shortages of chemotherapy drugs like cisplatin and carboplatin have caused delays and changes in treatment plans for some cancer patients. While the situation is improving, shortages still exist for some drugs. Staying informed is crucial, and the FDA is actively tracking drug shortages to mitigate them. It's important to comm…

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Legal Minute: Don’t Ignore State Registrations 0:35

9d ago0:35

0:35

We discuss how failure to register with the appropriate state boards of Pharmacy as a drug or device manufacturer can lead to severe consequences. These consequences include 1. Hefty fines, revoked licenses, and even legal charges, potentially ruining your business. 2. Additionally, non-compliance can result in reputational damage, eroding public t…

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Legal Minute: 6 Crucial Mistakes in Informed Consent 0:59

13d ago0:59

0:59

We discuss six critical errors in the informed consent process: 1. Exclusion of Principal Investigator: PI was not allowed to engage in the informed consent process. 2. Lack of Detailed Discussion: Staff members did not take the time to thoroughly discuss the study's potential benefits and risks with prospective subjects. 3. Inadequate Training: Co…

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Legal Minute: What is informed consent in clinical trials? 0:46

17d ago0:46

0:46

Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of participating in a study. This process involves full disclosure of information, allowing subjects to ask questions and address concerns with a knowledgeable medical professional. For minors, parental inv…

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Stop Risky Ads: Class Actions Could Cost You 22:53

20d ago22:53

22:53

In this podcast, we discuss the following: Recent updates from the courts in class action lawsuits. Difference between equity and law. Demerging or diverging equity and law. Dictionaries used by courts to interpret contracts. Update on Johnson and Johnson baby powder case (Suing plaintiff’s witnesses for defamation and false advertising) Experts ne…

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Legal Minute: How do drugs work? 0:14

25d ago0:14

0:14

Darshan explains that drugs work by either enhancing or inhibiting processes that already occur in the body. Put simply, they amplify or reduce the body's natural functions. This fundamental principle underscores how drugs interact with our biology.Av Darshan Kulkarni

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5 Surprising Causes of Life Science Deal Failures 2:08

30d ago2:08

2:08

We discuss the five common reasons behind the failure of mergers, acquisitions and licensing deals in the life sciences industry. Inadequate understanding of capability, where focusing solely on financials without comprehending the target company's regulatory and compliance processes leads to failure. The side project dilemma, illustrated by Philip…

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Legal Minute: Is pharma bribing your doctor? 0:48

1M ago0:48

0:48

In this short, Darshan sheds light on the relationship between doctors and pharmaceutical companies. He explains how pharmaceutical companies often pay doctors to ensure they understand their drugs and promote their products. However, patients can now access information on what doctors are being paid by pharmaceutical companies through the CMS webs…

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Legal Minute: Drug Registrations that can’t be ignored 0:56

1M ago0:56

0:56

When acquiring a drug or device company, regulatory attorneys play a crucial role in ensuring compliance during the due diligence process. It's vital to recognize that registration with state and local authorities is often overlooked by these companies, who may mistakenly believe that FDA registration suffices. However, failure to register appropri…

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Legal Minute: Why do pharmacies take so long to fill prescriptions? 0:57

1M ago0:57

0:57

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, …

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Legal Minute: 3 Steps to Avoid Food Recalls 0:39

2M ago0:39

0:39

We cover three steps for preventing food recalls: Identify all potential hazards. Focus on known and foreseeable risks. Develop preventive controls for specific hazards. Ensure every bite is safe! Need help? Call Darshan at 302.252.6959.Av Darshan Kulkarni

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Legal Minute: Are dietary supplements as good as drugs? 0:44

2M ago0:44

0:44

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, preve…

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Legal Minute: Clinical Trial Record Retention Disasters 0:51

2M ago0:51

0:51

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 …

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Legal Minute: Why is your medicine so expensive? 0:47

2M ago0:47

0:47

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 re…

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McKinsey’s 2030 vision: A challenge for medical affairs 2:34

2M ago2:34

2:34

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 o…

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Legal Minute: 3 must-do takeaways for collecting diversity data in clinical trials 0:58

2M ago0:58

0:58

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 categ…

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Legal Minute: Are Brand and Generic Drugs Truly Different? 0:54

2M ago0:54

0:54

We explore the chemical similarities and key differences between brand-name and generic drugs. Learn about: Equivalence in active ingredients, as approved by the FDA. Exceptions: Narrow Therapeutic Index drugs and inactive ingredients. When to consult a doctor before switching brands. Listen to find out if you can save money without sacrificing qua…

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Legal Minute: Who's REALLY Responsible for a Clinical Trial Congruency review? 0:56

3M ago0:56

0:56

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…

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This Drug Ad is FULL of Red Flags (We Expose Them All!) 2:53

3M ago2:53

2:53

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 "Prove…

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7 ways to challenge FDA’s regulation of LDTs 2:57

3M ago2:57

2:57

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, lever…

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Legal Minute: eBay’s $59 Million Drug-Making Problem 0:40

3M ago0:40

0:40

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 illeg…

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Legal Minute: Neuralink is a Game-Changer: 3 Lessons You Can't Afford to Miss 0:59

3M ago0:59

0:59

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 s…

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Legal Minute: Off-label marketing not ok again? 0:46

3M ago0:46

0:46

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-l…

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Don't Become the Next Fraud Headline: Lawyer Reveals Compliance Traps 1:15

3M ago1:15

1:15

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 e…

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Legal Minute: 3 Insider Secrets for a Successful Medical Device Recall 0:59

3M ago0:59

0:59

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 sa…

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Key elements of a successful congruency review for clinical trial agreements 3:06

4M ago3:06

3:06

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. An…

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Why Private Equity firms are betting big on clinical research sites 0:58

4M ago0:58

0:58

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…

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5 Ways to Legally Share Off-Label Information 1:51

4M ago1:51

1:51

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 a…

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DOJ's "Get Out of Jail Free" card for pharma and device mergers? 8:04

4M ago8:04

8:04

Darshan discussed crucial updates to the Department of Justice's (DOJ) corporate enforcement policies, particularly impacting FDA-regulated industries like pharmaceuticals and medical devices. The DOJ's focus on mergers and acquisitions (M&A) emphasizes the importance of compliance professionals throughout the entire process. Key Highlights: 1. Cor…

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Legal Minute: 5 factors to get your digital speaker program approved 0:41

4M ago0:41

0:41

In this podcast, we discuss the legal and regulatory factors for securing approval for your digital speaker program. Key points include prioritizing audience privacy, adhering to FTC disclosure regulations, explicit audience definition, distinguishing between educational and promotional content, and navigating health versus product claims. Link to …

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Legal Minute: Decoding the FDA's prescription drug use related software guidance 0:59

4M ago0:59

0:59

FDA Issues Crucial Guidance on Prescription Drug Software! Darshan Kulkarni delves into the FDA's recent guidance on prescription drug-related software. The discussion revolves around three key considerations: 1. software functions, 2. end-user output, and 3. regulatory guidelines. Notably, the FDA emphasizes distinguishing between functions relyin…

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Congruency Review: The Game Changer 2:53

4M ago2:53

2:53

Insider Exposes crucial missing step in Clinical Trial Agreements activation - Congruency Review Details Revealed! In the clinical trial agreement activation pathway, the journey involves several critical steps. It begins with the signing of the Confidentiality Disclosure Agreement (CDA), followed by the study team's review of the protocol and feas…

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Legal Minute: 5 hacks to fast-track your speaker program reviews 0:27

4M ago0:27

0:27

Accelerate your digital speaker program review with these 5 game-changing strategies: Policy Creation & Training Pre-reviews AI-based Reviews Modular Reviews Applying Quality Learnings Across the Program Dive deeper into each strategy on our podcast! Watch the full podcast- https://www.youtube.com/watch?v=Ud8jn4c3cCM…

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Selecting your ideal subject recruitment partner 2:08

4M ago2:08

2:08

Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company's experience and expertise in a specific disease state or area, its reach (national, international, or local), and the associated costs. He warns against the trend of traditional marketing companies enteri…

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Your digital sales team’s success depends on these 5 compliance rules 5:00

4M ago5:00

5:00

We discuss five key legal and regulatory considerations for a digital sales force: Starting with updates to the Physician Payment Sunshine Act, emphasizing the need for training, robust internal controls, and monitoring. It also touches on guidance for interactions with healthcare professionals, emphasizing transparency and ethical practices. The S…

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Legal Minute: 3 FTC rules for winning comparative claims 0:25

5M ago0:25

0:25

We explore the crucial aspects outlined by the FTC regarding comparative claims in drug and device advertising. the paramount importance of transparency in promotional efforts, the pitfalls associated with broad generalizations, and the need for readiness in the face of scrutiny from both the FDA and the FTC. Providing a valuable intersection of ph…

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The risks and rewards of Clinical Research as a Care Option 2:23

5M ago2:23

2:23

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 Option (CRACO). While the concept seems promising, particularly for patients with conditions like rare diseases or cancer, it introduces a host of concerns. The alignment of Institutional Review Board …

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3 game changing ways the FDA says AI will transform drug development 1:48

5M ago1:48

1:48

In this podcast, we discuss artificial intelligence (AI) and machine learning, exploring their pivotal roles in drug development. AI, a fusion of computer science, statistics, and engineering, employs algorithms to perform tasks like learning, decision-making, and prediction. Within the context of drug development, we unravel three significant appl…

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Legal Minute: Comparative claim review by NAD 0:59

5M ago0:59

0:59

The National Advertising Division (NAD) recently examined a TV ad by Bravecto, comparing its flea and tick prevention product with NexGard's. The ad suggested Bravecto's greater effectiveness, disputed by NexGard. NAD sided with NexGard, emphasizing the need for clear and conspicuous disclosures in comparative advertising. In a separate case, Googl…

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5 foolproof ways to get your digital speaker program approved 2:52

5M ago2:52

2:52

In this podcast, five crucial considerations for obtaining approval for a digital speaker program are discussed: 1. Privacy Compliance: - Consider where audience data will be stored and ensure compliance with privacy laws (TCPA, CCPA, GDPR, etc.). - Prioritize secure handling of sensitive information and always obtain audience consent. 2. Transpare…

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Legal Minute: Prepare your Cosmetics Company for 2024 0:48

5M ago0:48

0:48

he recently issued FDA guidance mandates manufacturers, packers, and distributors to adhere to new standards, emphasizing mandatory product and facility registrations, creation of safety substantiation information, and implementation of adverse event reporting. Daron breaks down key definitions, clarifies information submission processes, and discu…

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How to get PRC to approve your ads quickly 4:08

5M ago4:08

4:08

In this podcast episode, we'll uncover five strategies to expedite the digital promotion review process. Starting with 1. Policy creation and training emphasizes aligning policies across platforms, incorporating key stakeholders' expectations, and ensuring consistency with relevant agreements and guidelines. 2. Pre-review meetings with marketing te…

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Legal Minute: 4 Must Do's When Choosing a Predicate Device for Your 510(k) 0:59

5M ago0:59

0:59

Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices for selecting a predicate device when preparing a 510(k) submission. This guidance underscores four key considerations. The draft guidance emphasizes the significance of technological characteristics. I…

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Legal Minute: FDA's Vision for the Future of IT 0:59

6M ago0:59

0:59

Darshan Kulkarni discusses the FDA's IT strategy for 2024 to 2027. The FDA aims to create a unified FDA ecosystem, promote cross-functional collaboration, and foster a more integrated organizational culture. Key goals include strengthening IT infrastructure, modernizing enterprise services, and optimizing the IT services portfolio for stable, resil…

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Legal Minute: FTC announces major revamp in 2024 enforcement strategy 0:52

6M ago0:52

0:52

In a significant update on September 19th, Samuel Levine, Director of the #FTC's Bureau of Consumer Protection, outlined the agency's key priorities at the National Advertising Division's annual conference. Levine emphasized a three-pillar enforcement agenda. The first pillar targets practices causing substantial consumer harm, While the second aim…

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23andMe data breach: Is your genetic data the next big target for hackers? 1:17

6M ago1:17

1:17

This week, a data breach was disclosed by 23andMe, affecting 6.9 million users and compromising their genetic data information. The incident raises significant concerns about data privacy and security. It's important to note that while some perceive this as a violation of HIPAA, it typically doesn't apply to direct-to-consumer genetic testing servi…

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Ultimate Guide for Clinical Trial Publishing Rights in Large Academic Centers | Istvan Fekete 30:44

6M ago30:44

30:44

Guest Istvan Fekete discusses what large academic medical institutions are responsible for that sponsors and other commercial entities are generally not. Key considerations include the complexities of handling publication rights, the impact of tax-exempt municipal bonds on project restrictions, ensuring equal patient treatment, the reality of unive…

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FDA's off-label trap: 7 reasons for uncertainty 3:46

6M ago3:46

3:46

In this video,, the focus is on the growing interest in digital engagement programs among FDA-regulated companies, but it also addresses the concerns raised by regulatory agencies such as the FDA, DOJ, FTC, and OIG. The discussion revolves around the risk-based review of outward-facing information shared by medical device companies. The podcast del…

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Legal Minute: 3 ways #pharmacies are fighting high generic drug prices! 0:55

6M ago0:55

0:55

Darshan Kulkarni talks about how the generic drug industry is facing several challenges that are impacting profitability, including: 1. Pressure from insurers to lower prices, 2. Rising costs of manufacturing and distribution, 3. Inflation, 4. Supply chain disruptions and 5. Increased competition from other generic companies Pharmacies are fighting…

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