DarshanTalks Podcast

Darshan Kulkarni discusses the FDA's IT strategy for 2024 to 2027. The FDA aims to create a unified FDA ecosystem, promote cross-functional collaboration, and foster a more integrated organizational …

In a significant update on September 19th, Samuel Levine, Director of the #FTC's Bureau of Consumer Protection, outlined the agency's key priorities at the National Advertising Division's annual conf…

This week, a data breach was disclosed by 23andMe, affecting 6.9 million users and compromising their genetic data information.

The incident raises significant concerns about data privacy and securit…

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 o…

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, DO…

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 manufa…

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, a…

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 …

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 F…

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, …

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 J…

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…

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 pr…

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…

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, highligh…

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 companie…

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 emphasi…

 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 int…

 We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices raise concerns regarding safety, efficacy, and misleading prom…

 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 copy…