DarshanTalks Podcast

Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of participating in a study. This process involves full…

1. Recent updates from the courts in class action lawsuits. 
2. Difference between equity and law. 
3. Demerging or diverging equity and law. 
4. Dictionaries used by cour…

Darshan explains that drugs work by either enhancing or inhibiting processes that already occur in the body. Put simply, they amplify or reduce the body's natural functions. This fundamental principl…

We discuss the five common reasons behind the failure of mergers, acquisitions and licensing deals  in the life sciences industry. 

Inadequate understanding of capability, where focusing solely on fin…

In this short, Darshan sheds light on the relationship between doctors and pharmaceutical companies. He explains how pharmaceutical companies often pay doctors to ensure they understand their drugs a…

When acquiring a drug or device company, regulatory attorneys play a crucial role in ensuring compliance during the due diligence process. It's vital to recognize that registration with state and loc…

Have you ever wondered why your prescription takes what feels like an eternity to fill at the pharmacy? Darshan will shed some light on the process. 

When you drop off your prescription, the pharmacis…

We cover three steps for preventing food recalls:
Identify all potential hazards.
Focus on known and foreseeable risks.
Develop preventive controls for specific hazards.
Ensure every bite is safe! Need h…

In this video, Darshan distinguishes between dietary supplements and drugs. The 
primary difference lies in the claims they can make. Dietary supplements are treated as foods and can only make limited…

Here are 5 clinical trial record retention problems.
1. Fabricating Data and Documentation,
2. Forging the Principal Investigator's signatures,
3. Data Manipulation,
4. Misappropriating Samples and 
5. Fo…

Bringing a drug to market is a costly and intricate process, averaging $2.3 billion. This expense encompasses multiple levels of testing, ranging from small animals to extensive human trials. The dru…

McKinsey’s vision for Medical Affairs in 2030 envisions profound integration of digital tools, analytical innovation, evidence generation, and leadership transformation. However, this vision faces a …

In an ideal world, every patient in clinical trials would feel truly represented. In this video, Darshan Kulkarni outlines three crucial takeaways for collecting diversity data in clinical trials, fo…

We explore the chemical similarities and key differences between brand-name and generic drugs. Learn about:
Equivalence in active ingredients, as approved by the FDA.
Exceptions: Narrow Therapeutic Ind…

In this short, we discuss who is responsible for a congruency review in clinical trials. Our guest Istvan Fekete emphasizes that both pharmaceutical companies and research sites share the responsibil…

Today, we analyze a fictional drug advertisement, identifying and highlighting the nine key unethical and non-compliant elements.
- Misleading Information: The claim "The End of High Blood Pressure" s…

The FDA's announcement of its intention to regulate Lab Developed Tests (LDTs) in line with medical device regulations has sparked concerns among developers, anticipating significant financial implic…

eBay found itself as an unexpected marketplace for pill-making equipment, resulting in the company paying a hefty $59 million for facilitating the sale of such equipment. In our video, Darshan delves…

In a recent announcement, Elon Musk's company Neuralink revealed the successful implantation of a brain device in a human, pushing the boundaries of neurotechnology.
 In our latest short, we discuss k…

In the US v. Facteau case, a recent development adds complexity to the FDA's ongoing struggle with off-label communications, particularly in light of the SIUU guidance and the CFL guidance. The First…