DarshanTalks Podcast
Episodes
Selecting your ideal subject recruitment partner
22 Jan 2024
Contributed by Lukas
Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company'...
Your digital sales team’s success depends on these 5 compliance rules
19 Jan 2024
Contributed by Lukas
We discuss five key legal and regulatory considerations for a digital sales force: Starting with updates to the Physician Payment Sunshine Act, emphas...
Legal Minute: 3 FTC rules for winning comparative claims
16 Jan 2024
Contributed by Lukas
We explore the crucial aspects outlined by the FTC regarding comparative claims in drug and device advertising. the paramount importance of transpare...
The risks and rewards of Clinical Research as a Care Option
14 Jan 2024
Contributed by Lukas
In this podcast, we explore a groundbreaking shift where clinical research is emerging as a viable care option, known as Clinical Research as a Care O...
3 game changing ways the FDA says AI will transform drug development
11 Jan 2024
Contributed by Lukas
In this podcast, we discuss artificial intelligence (AI) and machine learning, exploring their pivotal roles in drug development. AI, a fusion of comp...
Legal Minute: Comparative claim review by NAD
10 Jan 2024
Contributed by Lukas
The National Advertising Division (NAD) recently examined a TV ad by Bravecto, comparing its flea and tick prevention product with NexGard's. The...
5 foolproof ways to get your digital speaker program approved
05 Jan 2024
Contributed by Lukas
In this podcast, five crucial considerations for obtaining approval for a digital speaker program are discussed:1. Privacy Compliance: - Consider ...
Legal Minute: Prepare your Cosmetics Company for 2024
02 Jan 2024
Contributed by Lukas
he recently issued FDA guidance mandates manufacturers, packers, and distributors to adhere to new standards, emphasizing mandatory product and facili...
How to get PRC to approve your ads quickly
29 Dec 2023
Contributed by Lukas
In this podcast episode, we'll uncover five strategies to expedite the digital promotion review process. Starting with1. Policy creation and trai...
Legal Minute: 4 Must Do's When Choosing a Predicate Device for Your 510(k)
21 Dec 2023
Contributed by Lukas
Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices fo...
Legal Minute: FDA's Vision for the Future of IT
14 Dec 2023
Contributed by Lukas
Darshan Kulkarni discusses the FDA's IT strategy for 2024 to 2027. The FDA aims to create a unified FDA ecosystem, promote cross-functional colla...
Legal Minute: FTC announces major revamp in 2024 enforcement strategy
10 Dec 2023
Contributed by Lukas
In a significant update on September 19th, Samuel Levine, Director of the #FTC's Bureau of Consumer Protection, outlined the agency's key pr...
23andMe data breach: Is your genetic data the next big target for hackers?
07 Dec 2023
Contributed by Lukas
This week, a data breach was disclosed by 23andMe, affecting 6.9 million users and compromising their genetic data information. The incident raises si...
Ultimate Guide for Clinical Trial Publishing Rights in Large Academic Centers | Istvan Fekete
06 Dec 2023
Contributed by Lukas
Guest Istvan Fekete discusses what large academic medical institutions are responsible for that sponsors and other commercial entities are generally n...
FDA's off-label trap: 7 reasons for uncertainty
04 Dec 2023
Contributed by Lukas
In this video,, the focus is on the growing interest in digital engagement programs among FDA-regulated companies, but it also addresses the concerns ...
Legal Minute: 3 ways #pharmacies are fighting high generic drug prices!
01 Dec 2023
Contributed by Lukas
Darshan Kulkarni talks about how the generic drug industry is facing several challenges that are impacting profitability, including:1. Pressure from i...
Pharma Industry Secrets: The Surprising Truth About DEI | Celia Daniels
24 Nov 2023
Contributed by Lukas
Recently, Celia Sandhya Daniels was announced to be one of the top 20 LGBTQ leaders in Bio Pharma by Endpoints News.In this episode, We're ventur...
Case Study: Academic Research Center Misconduct
15 Nov 2023
Contributed by Lukas
The case study on academic research center misconduct highlights the urgency to address and prevent such issues in the field. Instances of research mi...
Legal Minute: FTC Cracking Down on AI- 3 Must-Know Tips to Stay Compliant
11 Nov 2023
Contributed by Lukas
Planning to incorporate artificial intelligence into your business in 2024? Stay informed about the Federal Trade Commission's (FTC) expectations...
Project management as a clinical research game-changer
05 Nov 2023
Contributed by Lukas
Jessica Thompson discusses how project management can be a game-changer in clinical research. We talk about how poor project management can lead to ...
Legal Minute: 5 Must-Do’s for Virginia Tech’s FBRI to combat research fraud
31 Oct 2023
Contributed by Lukas
Virginia Tech recently received a $50 million gift from the Red Gates Foundation for Health Sciences research expansion. In light of recent news about...
Legal Minute: Pharmacy Closing Checklist: 7 Must Do's
26 Oct 2023
Contributed by Lukas
We discuss the 7 things to do before closing your pharmacy:1. Return your DEA registration,2. Notify the Board of Pharmacy,3. Dispose of controlled su...
FDA Approval for LDTs Made Easy
22 Oct 2023
Contributed by Lukas
The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensu...
Legal Minute: Pharmacist fraudster found guilty
19 Oct 2023
Contributed by Lukas
On September 5th, 2023, a Miami jury found a medical clinic owner and pharmacist guilty of falsifying and fabricating clinical trial data. We highlig...
AI's Complex Role: Creator, Copycat or Both?
15 Oct 2023
Contributed by Lukas
In this episode, guest Dave Bulger delves into the intricate role of AI, questioning whether it functions as a creator, a copycat, or perhaps both. Da...
FDA warns 8 companies including Walgreens selling unapproved eye products
10 Oct 2023
Contributed by Lukas
The FDA has taken action by sending warning letters to eight companies that have been marketing unapproved eye products, potentially violating federal...
Why the FDA’s plan to use one pagers will fail
05 Oct 2023
Contributed by Lukas
FDA is suggesting the use of one-pagers to provide essential drug information to patients. Past attempts faced challenges, such as one-size-fits-all c...
Supercharge your Marketing Approval Process based on these Concept Review Tips
03 Oct 2023
Contributed by Lukas
In this episode, we’ll discuss how to speed up your marketing approval process with these must know concept review tips. We will talk to Heather M...
Testosterone parties and unapproved biohacks: Is it worth the risk? #darshantalks
01 Oct 2023
Contributed by Lukas
We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices ra...
Generative AI…confidently spews BS!
30 Sep 2023
Contributed by Lukas
AI expert Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limita...
Testosterone parties and unapproved biohacks: Is it worth the risk? #darshantalks
28 Sep 2023
Contributed by Lukas
We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices ra...
Research Fraudster Banned by the FDA
28 Sep 2023
Contributed by Lukas
Mayya Tatsene has been issued a final debarment order by the FDA. The reason for the debarment stems from violating FDA regulations concerning clini...
How does CTP regulate tobacco? | Micah Berman
26 Sep 2023
Contributed by Lukas
The FDA's Center for Tobacco Products (CTP) was created in 2009 to regulate tobacco products. Micah Berman worked at CTP from 2011-2012. He dis...
60 second reveal: 3 Regulatory authorities that can make or break your pharma or device sale
24 Sep 2023
Contributed by Lukas
Darshan Kulkarni emphasizes that companies considering #acquisitions must be ready for scrutiny from multiple agencies: FDA, FTC, DOJ, and OIG. FDA ...
Maximizing FDA meetings: Getting the best out of every encounter | Ashley Preston
23 Sep 2023
Contributed by Lukas
In this episode, the focus is on planning #FDA meetings and the significance of pre-IND meetings. We discuss how pre-IND meetings are crucial for id...
The role of decentralized trials in the traditional landscape | Isaac Rodriguez- Chavez
02 Sep 2023
Contributed by Lukas
Isaac Rodriguez-Chavez discusses the role and the significance of the Decentralized Clinical Trials guidance. We discuss the following: What are d...
The Essential Guide to 7 Types of Clinical Trial Agreements
27 Aug 2023
Contributed by Lukas
Istvan Fekete and Darshan Kulkarni discuss the 7 types of clinical trial agreements (CTAs). CTAs Explored Include: Industry-Sponsored Trials, Ph...