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 ...
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Subscriber-only episode 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 perspective on AI in clinical trials, presented by Dr. Elzarrad. Overview of the Yale St…
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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 promotional compliance within the pharmacy industry, and we're here to explore them in detail. In a landmark case…
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Navigating FDA's clinical trial expectations after approval
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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-world data for long-term safety and effectiveness. Think of them as an extension of the initial research phase, but in a real-w…
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Legal Minute: Do dietary supplements interact with drugs?
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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 drug-like claims and can interact with medications. Common examples include grapefruit juice and vitamin K, whi…
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How Expert Pharma Marketers Navigate Privacy
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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: 1. Consent Management: Clear communication about data usage is essential, aligning with regulations like CCPA and GDPR. See…
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Hiring New Employees in PharmaTech Companies
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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 discussed her journey from freelance consultancy to joining Weave, highlighting the unique challenges and o…
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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. Ignoring Pharma Laws: Telehealth companies might not adhere to pharma marketing laws and could act as agents for pharma due to…
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Why a food lawyer would stop your restaurant’s marketing?
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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 Charles Savanovich, recently pled guilty to conspiracy and misbranding seafood. Over six years, they sold over…
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Legal Minute: Why are there chemo drug shortages?
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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 complex global supply chain, and older generic drugs being unprofitable to produce. Government pressure on p…
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Are Pharma Giants Ignoring Clinical Trial Site Issues?
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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 movement Save Our Sites (SOS). Dr. Fox also explores issues with decentralized clinical trials, advocates f…
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Why Adverse Events Go Unreported in Clinical Trials
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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. This reluctance can lead to serious consequences, as seen in cases where significant events like hives, disru…
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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 health. They play a crucial role in various aspects: Firstly, patient advocates are instrumental in representing t…
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Why Drug Accountability Matters in Clinical Trials
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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. Clinical research organizations also conduct routine audits to verify drug accountability. However, instances o…
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Legal Minute: What do I do if my med is on shortage?
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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. Schedule an appointment with your doctor to discuss alternative medications that might be effective for you. It's crucial …
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5 reasons not to use AI in creating pharma marketing content
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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. 2. Bias: Questions arise regarding the sources of information, control over data, and addressing privacy concerns to prevent biases and …
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8 essential elements of a valid prescription
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In this episode, we discussed eight essential strategies to prevent prescription drug fraud and abuse: Verify the prescriber's identity. Know the prescriber's DEA number. Know your patient thoroughly. Verify prescription dates for validity; ensure prescriptions are current. Communicate directly with prescribers if any concerns arise. Request identi…
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In this episode we're joined by Heather McFalls, Director of Promotion Compliance at Otsuka Pharmaceutical Companies to discuss the evolving role of ad promo executives and the regulatory landscape in the pharmaceutical industry. Dive into the conversation as we explore the impact of regulatory bodies like the FDA, FTC, and NAD, and the importance …
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Legal Minute: 4 Ways to Get Unapproved Drugs Legally!
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Today, we discuss four legal pathways to acquire unapproved drugs. First, over-the-counter drugs offer a route as some bypass FDA approvals, relying instead on a nomograph. Second, compounded drugs crafted by pharmacists provide an alternative despite lacking FDA approval. Third, the FDA's new policy allows for state-imported drugs, provided certai…
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The 4 Building Blocks of Using AI in any Pharma Marketing Strategy
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We discuss the essential elements to ensure that your pharma marketing plan aligns with AI use: 1. Define Clear Goals: Establishing clear objectives is crucial for developing a comprehensive compliance plan for AI use. Without clear goals, executing a successful strategy becomes challenging. 2. Establish Policies and Procedures: Clearly defined pol…
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Legal Minute: Why Clinical Trials Are Right for You!
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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's important to note you might only receive the standard of care. Second, participation ensures closer monitoring by healthcare professionals. Third, it provides an opportunity to contribute to medic…
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Why Clinical Researchers Are Flocking to MedSpas
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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 combine beauty treatments with medical procedures, blurring the lines between pampering and healthcare. To navigate this complexity, they talk about MSOs, which are basically middlemen. MSOs let non-…
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Legal Minute: Why You Should Never Trust a Celebrity with Your Health
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Darshan explains why you shouldn’t Trust Celebrities When Choosing Your Drugs! Hidden Agendas: They're paid to promote, not give unbiased advice. Not Medical Experts: Trust your doctor's knowledge, not a celebrity's opinion. Oversimplified Info: 30-second ads can't tell the whole story. Not Personalized: Your doctor can give you the right advice fo…
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Recent pharmacy walkouts and closures at major chains highlight a critical issue: staffing shortages. Independent pharmacies are also at risk. Here are 5 tips for pharmacy owners and managers to prepare for potential temporary closures: Cross-Train Staff: Train front-end staff on basic pharmacy procedures (depending on state regulations) so they ca…
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Legal Minute: 5 Surprising Benefits of Ozempic!
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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 not have heard of: Liver Support: Early research suggests Ozempic could benefit liver health, but more studies are needed. Weight Loss Weapon: Ozempic has a weight-loss version, offering a powerful tool…
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In today's episode, we discuss AI-generated content in the pharmaceutical industry. AI has revolutionized content creation, but it's not without its legal and ethical dilemmas. Take, for instance, the New York Times' lawsuit against OpenAI, highlighting the contentious issue of data ownership. As pharma companies increasingly rely on AI for content…
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Legal Minute: Why does my drug cost so much?
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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 means a drug company spends between $420,000 and $630,000 daily during this process. Imagine going to a casino every day, betting that much money without knowing the outcome, for 10 to 15 years. What ki…
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AI for Promotions in FDA-Regulated Industries
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Join Darshan Kulkarni, a Food and Drug attorney, as he explores the dynamic intersection of artificial intelligence, drug and device promotion, and the law. In this podcast series, we'll dive deep into AI's role in promotional and non-promotional communications within the pharmaceutical and medical device industries. From regulatory compliance and …
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Legal Minute: Billion-Dollar Speaker Scheme!
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Speaker programs are events sponsored by drug and device companies where a physician or other healthcare professional (HCP) delivers a speech or presentation to fellow HCPs regarding a specific drug, device product, or disease state on behalf of the sponsoring company. Typically, the company compensates the speaker with an honorarium and may also p…
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Off-Label Risks: Compliance Matters Now More Than Ever
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We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry. We discuss the following: What does off-label mean from a reimbursement standpoint? Lessons from the US v. Eli Lilly 2009 case How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau How ar…
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6 Must-Knows Before Buying a Drug or Device Company
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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?
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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
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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 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
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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?
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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
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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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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. Support the Show.By Darshan Kulkarni
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5 Surprising Causes of Life Science Deal Failures
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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?
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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
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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?
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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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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. Support the Show.By Darshan Kulkarni
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Legal Minute: Are dietary supplements as good as drugs?
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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
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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?
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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
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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
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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?
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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?
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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!)
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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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