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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.
69 Episodes
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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 include1. Hefty fines, revoked licenses, and even legal charges, potentially ruining your business. 2. Additionally, non-compliance can result in reputational damage, eroding public trust and deterring potential partners. 3. Moreover, loss of distribution rights could leave you unable to serve customers in entire states...
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: Coordinators lacked knowledge about the study and lacked a research background, leading to insufficient information provided to participants.4. Unauthor...
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 involvement is required, and subjects have the right to withdraw consent at any time. It's not merely a form but an ongoing process that starts b...
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 need to be cautious to avoid false advertising allegations against them. Update on Maybelline 24-hour make-up case...
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.
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 Morris' venture into pharmaceuticals, emphasizing the importance of aligning with core business objectives. Clash of perspect...
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 website, as mandated by the Sunshine Act Law. This transparency allows patients to make informed decisions about their healthcare.
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 appropriately with state and local authorities could lead to sales restrictions within those jurisdictions. Each state has its own criteria for registratio...
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 your diet, and making sure it's covered by your insurance.This detailed process, ...
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.
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, the key distinction is in the level of proof required for th...
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 DairiesJoin 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 at 302-252-6959 for expert assistance with your clinical trial compliance program.
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 against potential risks and ensuring the drug's viability on a...
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 supervision, to share such information.This regulatory change p...
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 starting by asking about identity, specifically Hispanic and Latin...
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 quality!
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 vetting process. While pharmaceutical companies are responsible...
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 is unrealistic and unsubstantiated, making it misleading.3- Ignoring Risks and Side Effects:...
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 hearings provide direct avenues to voice concerns and influence final regulation...
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 consulting with consumer safety and regulatory lawyers before...
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