DarshanTalks Podcast

Guest Istvan Fekete discusses what large academic medical institutions are responsible for that sponsors and other commercial entities are generally not. Key considerations include the complexities of handling publication rights, the impact of tax-exempt municipal bonds on project restrictions, ensuring equal patient treatment, the reality of universities generating revenue from intellectual property, the distinct goals of principa...

In this video,, the focus is on the growing interest in digital engagement programs among FDA-regulated companies, but it also addresses the concerns raised by regulatory agencies such as the FDA, DOJ, FTC, and OIG. The discussion revolves around the risk-based review of outward-facing information shared by medical device companies. The podcast delves into seven hierarchical layers that dictate how organizations should approach com...

Darshan Kulkarni talks about how the generic drug industry is facing several challenges that are impacting profitability, including:

1. Pressure from insurers to lower prices,
2. Rising costs of manufacturing and distribution,
3. Inflation,
4. Supply chain disruptions and
5. Increased competition from other generic companies

Pharmacies are fighting back against these challenges by:

1. Bypa...

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 venturing into the captivating world of Diversity, Equity, and Inclusion (DEI) in the realm of pharmaceuticals and healthcare. Get ready for a journey that will unravel the mysteries and intricacies of DEI!

We’re joined by Celia Sunday Daniels, a seasoned professional wi...

The case study on academic research center misconduct highlights the urgency to address and prevent such issues in the field. Instances of research misconduct, as exemplified by the Miami case, have drawn the attention of regulatory agencies like the Department of Justice, emphasizing the need for stringent oversight and ethical conduct. Examining the fictional case of Padre Pio Hospital in Philadelphia reveals the complexities and...

Planning to incorporate artificial intelligence into your business in 2024? Stay informed about the Federal Trade Commission's (FTC) expectations. In his discussion, Darshan Kulkarni highlights the FTC's recommendations for AI:
FTC expects that AI will foster fair, open and competitive markets,
FTC intends to use its tools to challenge unfair and deceptive practices involving claims based on AI including the use o...

Jessica Thompson discusses how project management can be a game-changer in clinical research.  We talk about how poor project management can lead to delays, cost overruns, and regulatory violations, and that lawyers can play a role in ensuring that clinical research projects are managed effectively. Thompson emphasized the need for early planning and communication between all stakeholders involved in a clinical research project.

Virginia Tech recently received a $50 million gift from the Red Gates Foundation for Health Sciences research expansion. In light of recent news about research fraud prosecuted by the Department of Justice, it is crucial for the Fralin Biomedical Research Institute to implement robust research integrity policies.
Here are five key steps that the institute can take to address research fraud:
1.  develop and implement a clear...

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 substances appropriately,
4. Inventory your pharmacy and create a clear inventory list,
5. Keep all documentation, especially for controlled substances, for at least 2 years,
6. Know where your records are stored, as the DEA may request them later and

The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensure compliance, developers must adhere to a rigorous process.
 
Key steps include:
1) Develop a risk-based framework- 0:39- 1:03
2) Get pre-market clearance or approval- 1:04- 1:37
3) Quality control and quality assurance- 1:38- 2:04
4) Adhering to FDA guideline...

On September 5th, 2023, a Miami jury found a medical clinic owner and pharmacist guilty of falsifying and fabricating clinical trial data.
 
We highlight the significance of pharmacists recognizing red flags indicating potential fraud, including patients unknowingly or involuntarily enrolled in clinical trials.
 
Beyond the broader impact on public trust, pharmacists could face specific repercussions, such as discip...

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. Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limitations of generative AI, raises concerns about copyright in content generation, and explores AI's potential impact across industries. Dave unders...

The FDA has taken action by sending warning letters to eight companies that have been marketing unapproved eye products, potentially violating federal laws and risking consumer health. 

These companies include Boiron Inc, CVS Health, Dr. Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan USA or Similasan AG, TRP Company Inc., and Walgreens Boots Alliance Inc. 

These companies are now under increas...

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 content and patient trust issues. 
 
Darshan emphasizes that while the FDA's proposal is a step in the right direction, it must ensure that these one-pagers are comprehensive, accurate, and transparent. Patients often rely on healthcare providers and trusted sources like W...

 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 McFalls, Director of AD Promo at Organon. In this interview we will address the following questions: 
1.    How often do people do concept reviews? 
2.    Is it useful to have an attorney at the concept review stage? 
3.    Is the role of PRC advisory or quality-focused?
4...

 AI expert Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limitations of generative AI, raises concerns about copyright in content generation, and explores AI's potential impact across industries. Dave underscores that while LLMs can generate text, they lack true understanding. The conversation explores the challenges of scraping data for accu...

 Mayya Tatsene has been issued a final debarment order by the FDA. The reason for the debarment stems from violating FDA regulations concerning clinical trials. Specifically, Tatsene failed to test on the appropriate number of subjects, thus compromising the integrity and reliability of the trial data. How to Avoid this Fate: To sidestep such consequences, individuals and organizations must strictly adhere to FDA guidelines, which ...