All Episodes
DarshanTalks Podcast — 347 episodes
Pharmacy's Critical Role in Clinical Trial Compliance
The Wild Lizard Venom Origins of Ozempic
Unlicensed Medical Advice & The Legal Battle Over Character.AI
Sponsoring Cannabis Research
The New Era of Personal Consent Decrees
Why Private Membership Associations Fail FDA Scrutiny
The Hidden Reason Sites are Firing Recruiters
Don’t Let Your PI Walk Away With Your Study
Safe or Just "Not Dirty"? The Regulatory Gamble of Compounded Drugs
"Basically Employees" Isn't a Legal Category (And the OIG Knows It)
The Hidden Legal Risks of AI Sponsor Protocols
The $100M Mistake: Why AI-Generated Drugs May Not Be Patentable
Is AI replacing your Doctor?
Why the OIG Just Revolutionized Pharma Marketing (And What It Costs You)
6 Categories of "Bulk Data" That Could Land You in Federal Court.
The Utah Experiment: The Dangerous New Frontier of AI Prescribing
Is Your DTC Program a Kickback Trap?
The Hidden Death Sentence for Trial Sites
FDA "Screams": The Real Reason Your Snack Is At Risk
2 Laws More Dangerous Than HIPAA for Patient Engagement
"Invite-Only" Compliance Is Over: Is Your Cosmetic Company Ready?
Audit-Proof Your Site: The Training Gap Killing Your Contracts
15 Years in Prison for Marketing Fraud
Is your "Clinical Decision Support" tool actually an unregulated medical device?
The FDA’s New Political Enforcement Strategy
Why Your "Physician-Only" Ads Aren't Safe from Regulators
The Messy Reality of AI Prescriptions
Why Your Consultant’s Report Is a Legal Liability
Stop Reporting Results? The NIH’s "Get Out of Jail Free" Card
Final LGBTQ Individuals in clinical research
When the FDA Plays Politics
Your Site’s Background Check is Illegally Incomplete - Here is why
Is Your Off-Label Use Now a Federal Crime?
10,000 Specialists: A Futurist’s Vision for AI Healthcare
The Battle Over Weight Loss and Compounded Drugs
Why Cosmetic Ingredient Names Matter and What MOCRA Really Means - Interview with Heather Bustos
Compliance Isn’t a Deal Killer… Until It Is - Interview with Stephanie Trunk
Cosmetic ingredients the FDA doesn’t want you to use
Why Federal Agencies Are Targeting Executives
Why the New Food Pyramid Matters to You
Ex FDA Commissioner Robert Califf on FDA Authority, Politics, and the Health Crisis No One Wants to Name
Buying a Med Spa? GLP-1 Compliance Can Kill the Deal
New crown jewel valuing patient data
Your Staff is trained, but can you prove it?
What Happens When a Sponsor Walks Away Early?
Cosmetic Claims the FDA Hates
Biggest Legal Mistakes in Influencer Marketing
Your Mood, Energy, and Sleep Claims Might Be Regulated
Device Fail: The Legal Anatomy of a Faulty Implant Scandal
5 Documents the FDA Will Demand on Site — Are You Ready?
Cosmetic Marketing Mistakes That Trigger Regulators
Why Your Clinical Trial Contract Is Leaving Cash on the Table
Why Testimonials Can Get Your Brand Sued
How to Get Sponsors to Pay Faster than Net 90
Compliance Mistakes That Kill Pharma and Biotech Deals
Balance FDA Rules with FTC Advertising Requirements
Key Clauses in PI Contracts to Review
Compliance guru talks practical Insights on Speaker Programs
Trends in Small Life Sciences Transactions
Protect Your Site If a Sponsor Terminates Early
Are Pharma Chatbots Putting You at Regulatory Risk?
Are Your Cosmetic Company Records Ready for FDA Audits?
When Medical Affairs Becomes Commercial in Disguise
Serious Adverse Event Reporting Under MoCRA
Key SOPs for Clinical Trials
Payer Presentations Can Trigger Enforcement
Pharmacies v manufacturers
Is Clinical Research Ready for the new FDA?
Is your cosmetics company FDA-registered?
Will AI Replace Doctors in clinical research?
Risks in Direct-to-Patient Engagement
Inside 340B: Challenges, Controversies, and Opportunities
IRBs in 2025: What’s Really Changing?
3 Red Flags in Telemedicine Partnerships
What do PBMs do?
How AMCs Build Stronger Compliance Cultures Together
How One DME Scheme Cost Medicare $61 Million
FDA to Step Up Enforcement on Pharma Advertising
Top 5 Factors Determining AMC Funding
New Series Drop: Exploring AMCs in Clinical Research
Why Choose a Licensed Attorney Over a Consultant?
Marketing Problems by Hims & Hers and Lilly
Should Sponsors Share Site Feedback?
AI Marketing Playbook for Drug Companies
Should Sites Be Ready on Standby?
Eastern District of PA Targets Pharmacies
Telehealth Done Right
DOJ and HHS Launch FCA Fraud Task Force
Should Sponsors Cover Malpractice Insurance?
Instagram Post that Sparked FDA Warning Letter
Why Are So Many Doctors Getting Arrested?
How to Run Compliant Pharma Speaker Programs
Are You Picking the Wrong KOLs?
How KLF’s Client Base Evolved Over 20 Years
FDA Pushback on Accelerated Gene Therapy Approvals
Your DEI Program Could Trigger an FCA Case
Teva’s Charity Partnership Scrutinized
Is There a “Right” Way to Calculate FMV?
Can Non-Physicians Own Clinical Trial Sites?
The KLF Story You Haven’t Heard
Why Telehealth Platforms Are Getting Sued
Should Clinical Trial Sites Be Paid Differently?
How to Build an AI Compliance Program
What the Big Beautiful Bill Means for Trial Sites
Co-Pay Mistakes Can Trigger DOJ Action
NIH Grant Denials Ruled Discriminatory?
Are Speaker programs supposed to be salesy?
DTP Compliance Just Got Tricky
Should You Use AI to Draft Informed Consent?
Could You Survive a Surprise Pharmacy Audit?
Self-Reporting in Clinical Trials
$14M Fine Says This “Free” Offer Wasn’t Legal
Nonprofit Pharma Exists. Here is how it works
FTC Rules for Pharma Companies
Whistleblowing in Clinical Trials: Is It Worth the Risk?
The Right Way to Do Medical Affairs on LinkedIn
Are We Paying Clinical Trial Patients Enough?
Pharma Ads Are Getting Canceled
Unpacking Screen Fail Payments in Research
Post-Trump Antitrust Rules Are Crushing Pharma Deals
7 Must-Know Steps to transfer medical device ownership
Responding to Site Findings
Is Your Medical Website Illegal?
Price Fixing in Clinical Research
DOJ Cracks Down on Pharmacy Fraud
Protect Your DTP Strategy
AI Clinical Trial Negotiators
SOPs: How Many is Too Many?
Is DTP Pharma’s Next Big Move?
Hackers Are Stealing Your Personal Health Data
How a “Medical Education” Program Became a $202M Fraud
Webinar Recap: What Sponsors Must Know About Fraud
AI-Powered Engagement is a Minefield
Webinar Update: Fraud Prevention Strategies Every Sponsor Needs
Are Your Promotional Claims Putting Your Company at Risk?
Privacy Dangers Lurking in Clinical Trial Mergers
The FDA's Crisis Is Now Your Problem
Broken FDA, Big Consequences
You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations
Essential Due Diligence Steps for Clinical Research M&A
Is AI Telemarketing Strategy Illegal?
No Clinical Trial Waste
The Real Meaning of Audit-Readiness in Clinical Research
Ordinary People Are Changing Medicine
Investor Influence Can Trigger FCA Violations
Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons
Clinical Trial Site M&A: What Most Get Wrong
Future-Proof Sites: SOS Insights Revealed
Why Food M&A Deals Collapse—And How to Prevent It
Non-Compliance Led to QOL Medical's $47M Settlement
FDA Regulatory Submissions: Challenges, Trends, and Future Predictions
How to do a VR promo check - Carly Schaecter gives us her advice
Diversity Matters in Clinical Trials
EMA’s LLM Guidelines Impact Life Sciences
How to Network Like a Pro at Conferences
Getting Ready for SOS 2025: FDA 483s, SOPs, and Site Survival
Maximizing Site Value
5 Key Areas to Review in Clinical Trial Agreements
Discussing Stem Cell Research Opportunities with a Research Site Owner
Quality Management: A Must in Clinical Trial Contracts
AI-Powered Chatbots in Pharma Sales and Education
Will New Tariffs Disrupt Your Next Pharma Deal?
Protecting Patient Data in a Changing Regulatory Landscape
Off-Label Promotion Changes in 2025
Turning Physicians into Leaders
Key Regulatory Agencies in Pharma M&A
Does E6 (R3) Blur the Line Between GCP and Privacy Laws?
RFK Jr. Confirmed as HHS Secretary: What It Means for Healthcare Policy
America’s Research Future in Jeopardy
Trump Administration’s NIH cuts: Will they cripple US medical research?
DEI Under Trump: What It Means for Clinical Trials
CAPA & RCA: A Must for Pharma M&A
Trump Targets Indirect Costs in NIH Funding
The USAID Halt and Its Consequences for Clinical Research
Ebola Vaccine Trial in Record Time!
Your Clinical Trial Site M&A Agreement is Exposing You to Risk
What Does ICH E6 R3 Say About Returning Data to Participants?
Navigating the Ongoing HHS Communication Freeze
Ordinary People Are Changing Medicine
Trump’s First 10 Days: The Impact on Clinical Trials
Selling a Business with Issues
Breaking Down GCP E6(R3)
AdvaMed 7 rules for Essential AI Innovation
Teva’s Case Should Shape Your Pharma Strategy
AI’s Impact on Healthcare: Liability, Ethics, and Responsibility
Four Types of Research related Grant Fraud
Defining Scope in Due Diligence Transactions
Clinical Trial Checklist
Presidential Changes and Impact on Drug Related Misinformation
Prep for Selling Your Company!
Top Tips for Starting a Clinical Trial Site
When Drug Reps Visit: Darshan Reacts
Is Pfizer competing with your pharmacy?
Talking to a Functional Medicine Doctor
Four Types of Research related Grant Fraud
Leveraging AI and RWD to Reshape Drug Trials!
DCTs in Oncology: Can They Work?
Marketing Due Diligence in Stem cell M&A Transactions
Why Are PBMs Blocking Your Meds? - Darshan reacts
Misleading Ads: Ad laws and Consumer Protection for Marketers
5 Common Clinical Trial Site Failures
Faster FDA Recalls
IRB Challenges and Updates for 2024
Is the Polio Vaccine Safe?
FDA blue print to discuss off label topics
Opportunities AI provides in Clinical Research
Telehealth and Biohacking: A Risky Combination
Is the FDA’s Response to AI Falling Behind?
Healthcare Is in Crisis: How do we fix it?
Will RFK Break Pharma?
Fake data in Clinical Trials
Darshan Fixes Big Pharma Misconceptions
How Trump’s Tariffs will Disrupt Clinical Trials and Drug Marketing?
Why China is Targeting Top Scientists!
Trump’s Bold Picks Shake Up Life Sciences
3 Regulatory Opportunities in Clinical Trials!
Don't Take Non-Prescription Ozempic or other Weight Loss Drugs
Clinical Trial Principal Investigator Duties in Clinical Trials
Supreme Court Redefined Pharma Marketing Rules
AI concerns in M&A for Life Sciences
Trump Teams Potential Changes to Healthcare
Can AI Rewrite the Rules of Clinical Trials?
Ad Promo Review in Pharma - How Far is Too Far?
Why Staff Training Problems are a liability for Your Clinical Trial site
Neuralink: Breakthrough or Marketing Hype?
Telehealth Compliance Crisis: DOJ exposes $2.75B Fraud!
Should You Go In-House or Outsource Your Advertising Compliance?
Research fraud tainting pharma per Nature Article
Influencers are NOT KOLs. Know your Needs!
AI and Clinical Trials: Faster Results, Bigger Risks?
Eli Lilly’s Unexpected Shift on Use of Mounjaro!
Are CROs Losing Relevance in the Age of DCTs?
Managing Risks in Life Science Mergers and Acquisitions with Strategic Insurance
Can a Pharmacist Override Your Doctor's Prescription?
FDA Concerns About AI’s impact on Good Clinical Practices
Patient Advocates Could Cost You Millions
Managing Risks in Life Sciences Mergers and Acquisitions
How do pharmacists’ read doctors’ cursive letters?
AI Data Ownership in Pharma
Role of Tech Transfer in Clinical trial agreements
Why are medicine names so complicated?
Fixing Congruency Reviews in 8 Minutes
The Dark Side of Med Device Kickbacks
Which Hair Loss Treatment Is Right for You?
Analyzing the Publication Rights Clause in CTAs
What Really Starts Pharmacy Investigations?
Is your clinical trial AI racist?
Another Pharmacy owner Jailed in Fraud Case
Navigating FDA's clinical trial expectations after approval
Legal Minute: Do dietary supplements interact with drugs?
How Expert Pharma Marketers Navigate Privacy
Hiring New Employees in PharmaTech Companies
3 Hidden Dangers of Telehealth Marketing
Why a food lawyer would stop your restaurant’s marketing?
Legal Minute: Why are there chemo drug shortages?
Are Pharma Giants Ignoring Clinical Trial Site Issues?
Why Adverse Events Go Unreported in Clinical Trials
Who are patient advocates?
Why Drug Accountability Matters in Clinical Trials
Legal Minute: What do I do if my med is on shortage?
5 reasons not to use AI in creating pharma marketing content
8 essential elements of a valid prescription
No more lawyers in PRC?
Legal Minute: 4 Ways to Get Unapproved Drugs Legally!
The 4 Building Blocks of Using AI in any Pharma Marketing Strategy
Legal Minute: Why Clinical Trials Are Right for You!
Why Clinical Researchers Are Flocking to MedSpas
Legal Minute: Why You Should Never Trust a Celebrity with Your Health
Essential tips for pharmacy shutdowns
Why Clinical Researchers Are Flocking to MedSpas
Legal Minute: 5 Surprising Benefits of Ozempic!
Who Owns AI Generated Content in Pharma?
Legal Minute: Why does my drug cost so much?
AI for Promotions in FDA-Regulated Industries
Legal Minute: Billion-Dollar Speaker Scheme!
Off-Label Risks: Compliance Matters Now More Than Ever
6 Must-Knows Before Buying a Drug or Device Company
Legal Minute: Are there chemo drug shortages?
Legal Minute: Don’t Ignore State Registrations
Legal Minute: 6 Crucial Mistakes in Informed Consent
Legal Minute: What is informed consent in clinical trials?
Stop Risky Ads: Class Actions Could Cost You
Legal Minute: How do drugs work?
5 Surprising Causes of Life Science Deal Failures
Legal Minute: Is pharma bribing your doctor?
Legal Minute: Drug Registrations that can’t be ignored
Legal Minute: Why do pharmacies take so long to fill prescriptions?
Legal Minute: 3 Steps to Avoid Food Recalls
Legal Minute: Are dietary supplements as good as drugs?
Legal Minute: Clinical Trial Record Retention Disasters
Legal Minute: Why is your medicine so expensive?
McKinsey’s 2030 vision: A challenge for medical affairs
Legal Minute: 3 must-do takeaways for collecting diversity data in clinical trials
Legal Minute: Are Brand and Generic Drugs Truly Different?
Legal Minute: Who's REALLY Responsible for a Clinical Trial Congruency review?
This Drug Ad is FULL of Red Flags (We Expose Them All!)
7 ways to challenge FDA’s regulation of LDTs
Legal Minute: eBay’s $59 Million Drug-Making Problem
Legal Minute: Neuralink is a Game-Changer: 3 Lessons You Can't Afford to Miss
Legal Minute: Off-label marketing not ok again?
Don't Become the Next Fraud Headline: Lawyer Reveals Compliance Traps
Legal Minute: 3 Insider Secrets for a Successful Medical Device Recall
Key elements of a successful congruency review for clinical trial agreements
Why Private Equity firms are betting big on clinical research sites
5 Ways to Legally Share Off-Label Information
DOJ's "Get Out of Jail Free" card for pharma and device mergers?
Legal Minute: 5 factors to get your digital speaker program approved
Legal Minute: Decoding the FDA's prescription drug use related software guidance
Congruency Review: The Game Changer
Legal Minute: 5 hacks to fast-track your speaker program reviews
Selecting your ideal subject recruitment partner
Your digital sales team’s success depends on these 5 compliance rules
Legal Minute: 3 FTC rules for winning comparative claims
The risks and rewards of Clinical Research as a Care Option
3 game changing ways the FDA says AI will transform drug development
Legal Minute: Comparative claim review by NAD
5 foolproof ways to get your digital speaker program approved
Legal Minute: Prepare your Cosmetics Company for 2024
How to get PRC to approve your ads quickly
Legal Minute: 4 Must Do's When Choosing a Predicate Device for Your 510(k)
Legal Minute: FDA's Vision for the Future of IT
Legal Minute: FTC announces major revamp in 2024 enforcement strategy
23andMe data breach: Is your genetic data the next big target for hackers?
Ultimate Guide for Clinical Trial Publishing Rights in Large Academic Centers | Istvan Fekete
FDA's off-label trap: 7 reasons for uncertainty
Legal Minute: 3 ways #pharmacies are fighting high generic drug prices!
Pharma Industry Secrets: The Surprising Truth About DEI | Celia Daniels
Case Study: Academic Research Center Misconduct
Legal Minute: FTC Cracking Down on AI- 3 Must-Know Tips to Stay Compliant
Project management as a clinical research game-changer
Legal Minute: 5 Must-Do’s for Virginia Tech’s FBRI to combat research fraud
Legal Minute: Pharmacy Closing Checklist: 7 Must Do's
FDA Approval for LDTs Made Easy
Legal Minute: Pharmacist fraudster found guilty
AI's Complex Role: Creator, Copycat or Both?
FDA warns 8 companies including Walgreens selling unapproved eye products
Why the FDA’s plan to use one pagers will fail
Supercharge your Marketing Approval Process based on these Concept Review Tips
Testosterone parties and unapproved biohacks: Is it worth the risk? #darshantalks
Generative AI…confidently spews BS!
Testosterone parties and unapproved biohacks: Is it worth the risk? #darshantalks
Research Fraudster Banned by the FDA
How does CTP regulate tobacco? | Micah Berman
60 second reveal: 3 Regulatory authorities that can make or break your pharma or device sale
Maximizing FDA meetings: Getting the best out of every encounter | Ashley Preston
The role of decentralized trials in the traditional landscape | Isaac Rodriguez- Chavez
The Essential Guide to 7 Types of Clinical Trial Agreements