x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

PODCAST

DarshanTalks Podcast

Darshan Kulkarni

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

science life sciences

All Episodes

1:26

5 reasons not to use AI in creating pharma marketing...

DarshanTalks Podcast ·

2024/07/07

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 comply with regulatory standards set by organizations like the FDA and FTC.3. La...

en-us

1:03

8 essential elements of a valid prescription

DarshanTalks Podcast ·

2024/07/06

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 identification when necessary.Act decisively if fraud is suspected—never dispense suspicious prescriptions and report incidents promptly.Recognize and report m...

en-us

12:16

No more lawyers in PRC?

DarshanTalks Podcast ·

2024/07/04

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 of compliance in avoiding legal pitfalls. Plus, learn valuable insights on the role of legal and compliance in navigating the complexities of ad pr...

en-us

0:53

Legal Minute: 4 Ways to Get Unapproved Drugs Legally!

DarshanTalks Podcast ·

2024/07/02

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 certain protocols are adhered to. Lastly, individuals can legally import drugs for personal use from abroad within specified limits. F...

en-us

0:51

Legal Minute: Why You Should Never Trust a Celebrity...

DarshanTalks Podcast ·

2024/06/18

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 for your needs.Ditch the Hype, Talk to Your Doctor!Support the Show.

en-us

2:09

Essential tips for pharmacy shutdowns

DarshanTalks Podcast ·

2024/06/16

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 can assist with paperwork like taking in prescriptions and completing end-of-day tasks.Stock Up on Prescriptions: Anticipate closures by keeping ...

en-us

32:13

Why Clinical Researchers Are Flocking to MedSpas

DarshanTalks Podcast ·

2024/06/14

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-physicians handle the business side of a MedSpa, while a licensed physician oversees the actual medical services.Points discussed: What are meds...

en-us

0:45

Legal Minute: 5 Surprising Benefits of Ozempic!

DarshanTalks Podcast ·

2024/06/11

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 many don't know exists.Addiction Fighter: Ozempic might hold promise in combating alcohol and substance abuse (this one might surprise you!).H...

en-us

7:00

Who Owns AI Generated Content in Pharma?

DarshanTalks Podcast ·

2024/06/08

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 generation, they must navigate murky waters to ensure compliance with existing regulations and respect for intellectual property rights.Controllin...

en-us

0:48

Legal Minute: Why does my drug cost so much?

DarshanTalks Podcast ·

2024/06/07

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 kind of return would you expect on that investment? That's why drugs are so expensive.Support the Show.

en-us

0:57

AI for Promotions in FDA-Regulated Industries

DarshanTalks Podcast ·

2024/06/06

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 ethical considerations to the latest FDA guidance, we'll cover it all. Whether you're a legal professional, an industry insider, or simp...

en-us

0:44

Legal Minute: Billion-Dollar Speaker Scheme!

DarshanTalks Podcast ·

2024/06/05

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 provide remuneration, such as free meals, to attendees. Between 2017 and 2020, drug and device companies reportedly paid nearly $2 billion to HCPs f...

en-us

24:35

Off-Label Risks: Compliance Matters Now More Than Ever

DarshanTalks Podcast ·

2024/06/03

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 are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid? How are compounded drugs ...

en-us

1:31

6 Must-Knows Before Buying a Drug or Device Company

DarshanTalks Podcast ·

2024/05/30

Buying a Drug or Device Company? 6 Compliance Must-KnowsThinking 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 assessments, effective training, and clear reporting channels.Companies can now claw back bonuses from employees who break compliance rules.Accurate risk asse...

en-us

0:50

Are there chemo drug shortages?

DarshanTalks Podcast ·

2024/05/28

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 communicate with your doctor, who can provide the latest information and discuss alternative treatment options tailored to your needs.

en-us

0:35

Legal Minute: Don’t Ignore State Registrations

DarshanTalks Podcast ·

2024/05/24

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...

en-us

0:59

Legal Minute: 6 Crucial Mistakes in Informed Consent

DarshanTalks Podcast ·

2024/05/20

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...

en-us

0:46

Legal Minute: What is informed consent in clinical...

DarshanTalks Podcast ·

2024/05/16

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...

en-us

22:53

Stop Risky Ads: Class Actions Could Cost You

DarshanTalks Podcast ·

2024/05/13

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...

en-us

0:14

Legal Minute: How do drugs work?

DarshanTalks Podcast ·

2024/05/08

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.

en-us

299 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter