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

6:29

Pharma merger killers

DarshanTalks Podcast ·

2025/11/14

Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions. When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival. Darshan explains how regulators—...

en-us

1:08

Balance FDA Rules with FTC Advertising Requirements

DarshanTalks Podcast ·

2025/11/12

Brands often struggle to balance FDA cosmetic rules with FTC advertising standards. The FDA oversees labeling and determines whether a product is a cosmetic, drug, or soap, while the FTC enforces truth in advertising across all marketing. Claims like “clinically proven” require solid scientific evidence, and overreaching claims can trigger scrutiny from both agencies. For growing brands—especially those investing in digital marketing—regulatory compliance is essential. Aligning marketing clai...

en-us

6:14

Key Clauses in PI Contracts to Review

DarshanTalks Podcast ·

2025/11/10

Many clinical trial site leaders overlook critical risks hidden in physician employment agreements. These contracts often contain clauses that can expose sites to financial, legal, and operational danger if not carefully reviewed. Key Risks to Watch Out For: Compensation Structures: Incentives tied to patient enrollment can raise anti-kickback and fraud concerns. Payments should reflect fair market value for time and expertise, not results. Data Ownership: If not explicit, investigators may ...

en-us

13:11

Compliance guru talks practical Insights on Speaker...

DarshanTalks Podcast ·

2025/11/07

In this episode, host Darshan Kulkarni speaks with Joseph Keeney about speaker programs in the life sciences industry, exploring practical differences between small and large companies. They highlight that while fundamentals like compliance, pragmatism, and sound business principles apply across organizations, strong mitigating controls and adherence to legal and industry codes are critical. Joseph explains the importance of engaging with various business units to understand real plans, align...

en-us

12:46

Trends in Small Life Sciences Transactions

DarshanTalks Podcast ·

2025/11/05

Darshan Kulkarni in conversation with Nella Bloom, for an in-depth discussion on the current state of small business transactions, private equity trends, and the challenges of advising clients in an unpredictable market. Nella, an experienced attorney specializing in mergers and acquisitions and fractional general counsel services, explains how today’s business climate feels increasingly unstable. Rapid regulatory changes, unpredictable government responses, and evolving funding structures ha...

en-us

0:59

Protect Your Site If a Sponsor Terminates Early

DarshanTalks Podcast ·

2025/11/03

When sponsors terminate a clinical trial early, research sites may face financial losses for preparatory or ongoing work. To mitigate this risk, contracts should explicitly guarantee payment for all work performed up to the termination date, as well as reimbursement for non-cancellable expenses such as IRB fees, recruitment advertising, and staff training. Including a wind-down clause ensures compensation for necessary closeout activities—such as patient chart reviews, final visits, and data ...

en-us

5:34

Are Pharma Chatbots Putting You at Regulatory Risk?

DarshanTalks Podcast ·

2025/11/01

Pharmaceutical chatbots are increasingly used to answer patient drug questions, but they carry significant regulatory and compliance risks. While the FDA has issued guidance on AI in drug development and medical devices, it does not yet provide a framework for patient-facing drug Q&A. That means chatbots that discuss side effects, dosing, or interactions exist in a gray zone, and any missteps could trigger FDA enforcement. The FTC enforces truth in advertising and consumer protection. Mis...

en-us

1:08

Are Your Cosmetic Company Records Ready for FDA Audits?

DarshanTalks Podcast ·

2025/10/30

Companies must maintain thorough records to meet FDA inspection requirements, including safety substantiation files, labeling proofs, ingredient documentation, and adverse event logs. Adverse event logs must be retained for six years (three for small businesses), while registration and product listing records require annual updates. Organized, accessible, and up-to-date records are essential not only for compliance but also for growth, due diligence, and investor confidence. Compliance is a s...

en-us

6:11

When Medical Affairs Becomes Commercial in Disguise

DarshanTalks Podcast ·

2025/10/24

Darshan explores a critical question for life sciences companies: is your medical affairs team truly independent from commercial—or are you just pretending? In this episode of KLF Deep Dive, Darshan highlights why organizational charts alone are not enough to satisfy regulators. He explains that regulators focus on conduct, process, and intent, not PowerPoint slides. Using the 2013 GlaxoSmithKline settlement as a cautionary example, he demonstrates how blurred lines between medical and commer...

en-us

1:12

Serious Adverse Event Reporting Under MoCRA

DarshanTalks Podcast ·

2025/10/22

Under the Modernization of Cosmetics Regulation Act (MoCRA), reporting serious adverse events to the FDA is now mandatory. Companies must report serious incidents—such as hospitalizations, infections, disfigurement, or medically treated allergic reactions—within 15 business days. They must also maintain records of all adverse events for six years (or three years for small businesses). Practically, this requires setting up a system to capture and assess customer complaints, determine seriousne...

en-us

0:51

Key SOPs for Clinical Trials

DarshanTalks Podcast ·

2025/10/20

Darshan Kulkarni highlights that to stay compliant with the FDA, companies don’t need an exhaustive set of SOPs—just the essential ones. Inspectors primarily focus on SOPs covering informed consent, adverse event reporting, drug/device accountability, source documentation, PI oversight, protocol deviations, and record retention. He emphasizes keeping SOPs concise, practical, and enforceable, training staff consistently, and expanding them only as operational needs grow. Support the show

en-us

6:00

Payer Presentations Can Trigger Enforcement

DarshanTalks Podcast ·

2025/10/18

The boundary between scientific exchange and marketing in payer presentations is increasingly blurred, creating significant compliance and enforcement risks. While payers demand real-world evidence, comparative studies, and economic models beyond FDA-approved labeling, manufacturers must ensure all shared information is truthful, non-misleading, properly contextualized, and backed by competent and reliable scientific evidence. Key pitfalls include: Cherry-picking data without balanced limitat...

en-us

11:56

Pharmacies v manufacturers

DarshanTalks Podcast ·

2025/10/16

In this episode, Darshan Kulkarni speaks with Dae Lee about the growing conflict between pharmaceutical manufacturers and pharmacy benefit managers (PBMs) — and how it’s reshaping the U.S. drug supply chain. They unpack the recent dispute involving AstraZeneca, which alleges discrepancies between the number of branded claims submitted by pharmacies through PBMs and the rebates invoiced by those PBMs. The issue shines a spotlight on how PBMs control formulary access and drug distribution, ofte...

en-us

0:58

Is Clinical Research Ready for the new FDA?

DarshanTalks Podcast ·

2025/10/13

The FDA has criticized the industry for not taking advertising and promotion seriously and is now cracking down, as evidenced by hundreds of non-compliance letters. This raises the question: if similar scrutiny applied to clinical research, what would stand out first? Likely areas include proper informed consent, accurate recordkeeping, and potential upticks in physician enforcement. While this use of AI in research compliance hasn’t fully emerged yet, AI is already being applied in promotion...

en-us

1:06

Is your cosmetics company FDA-registered?

DarshanTalks Podcast ·

2025/10/11

Cosmetics companies must now register both their facilities and products with the FDA under the new MoCRArequirements, a shift from the previous voluntary system. Each facility must register, and product listings — including categories, ingredients, and manufacturing sites — must be submitted and updated annually. Growing companies face challenges in tracking reformulations, rebrandings, or acquisitions, as missing updates can trigger FDA enforcement or product removal. To scale safely, compa...

en-us

0:51

Will AI Replace Doctors in clinical research?

DarshanTalks Podcast ·

2025/10/09

Darshan discusses the potential role of AI in medicine. He believes fears of AI replacing doctors for diagnosis are currently overblown, as trust in physicians remains crucial. However, he suggests AI could assist with preliminary research tasks, such as reviewing inclusion/exclusion criteria and conducting initial screening. Have you seen AI being used in this manner? Support the show

en-us

2:49

Risks in Direct-to-Patient Engagement

DarshanTalks Podcast ·

2025/10/07

Direct-to-Patient (DTP) models are transforming how medications reach patients, moving beyond clinical research into commercial distribution. Originally developed to help rare disease trial participants avoid long travel to research sites, DTP has become a standard solution for improving patient access and convenience. Today, patients can receive small molecules, complex biologics, and even medical devices directly at home, making what was once exceptional now routine. Despite the benefits, D...

en-us

14:43

Inside 340B: Challenges, Controversies, and...

DarshanTalks Podcast ·

2025/10/01

Darshan Kulkarni speaks with Thomas Siepka, CEO of HCI Healthcare Consultants, to take a deep dive into the often-misunderstood world of the 340B drug pricing program. Drawing on Siepka’s extensive experience as a pharmacist and healthcare leader, they explore how the 340B program was designed to support covered entities—such as disproportionate share hospitals and federally qualified health centers—by requiring manufacturers to provide steep discounts. These savings allow organizations servi...

en-us

5:41

IRBs in 2025: What’s Really Changing?

DarshanTalks Podcast ·

2025/09/27

In this conversation, Edye Edens with Nyssa Towsley from UNLV, examine how today’s shifting funding landscape is reshaping IRB operations. Historically, IRBs were built around the assumption that most research would be government-funded. That assumption is being challenged, with changes in funding priorities and availability beginning to influence the volume and nature of submissions. At UNLV, for example, faculty research submissions show a slight dip in volume and a change in character. Wit...

en-us

2:49

3 Red Flags in Telemedicine Partnerships

DarshanTalks Podcast ·

2025/09/25

In this video, Darshan discusses recent enforcement trends show three weak spots to watch: Encounter Quality – If prescribers are just checking boxes without real patient relationships, it’s not care—it’s exposure. Demand documented standards, ID proofing, intake, decision support, and supervision. Don’t take claims at face value—audit them. Cash Flow Logic – Murky subscription fees, misuse of facility fees, or volume-driven compensation are red flags. Require transparent fee schedules, fair...

en-us

282 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