DarshanTalks Podcast

Darshan discusses the five most common clinical trial site issues:

1. Failure to Follow Investigational Plan: Treating clinical trials like routine medical practice instead of strictly following the p…

The FDA’s Center for Devices and Radiological Health (CDRH) has launched a groundbreaking initiative aimed at improving the efficiency and speed of recall communications for medical devices. 

Here are…

In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHRP, and the need for greater federal agency involv…

The polio vaccine, credited with eradicating a crippling disease in the U.S., faces renewed scrutiny after attorney Aaron Siri, linked to Robert F. Kennedy Jr., petitioned the FDA to revoke its appro…

FDA has changed its mind about off label marketing. Today, we're diving into how drug and device companies can effectively engage with payers and providers, exploring recent updates and guidelines. 

L…

Today, we're discussing the FDA's use of artificial intelligence (AI) to transform clinical trials.

AI is emerging as a cornerstone in clinical research, with the FDA recognizing its potential in seve…

The rise of biohacking has transitioned from a niche interest to a mainstream trend, particularly in the context of drugs like Ozempic and ketamine. While biohacking aims to enhance human performance…

The FDA’s current approach to AI in healthcare highlights significant gaps in regulatory preparedness. Although the FDA has approved thousands of AI-enabled tools, it still lacks the resources, clear…

In this episode, guest host Kate Woods and Darshan Kulkarni delve into current healthcare issues, including the unsettling news of the CEO of United Healthcare being shot. They discuss the broader im…

Robert F. Kennedy Jr. has announced plans for a presidential mandate to restore federal agencies, including the FDA, to the "gold standard" of scientific review. This bold proposal has significant im…

Florida medical clinic owner and staff were charged with falsifying clinical trial data. According to the indictment, from September 2015 to March 2018, the defendants at AMB Research Center in Miami…

In this reaction video, Darshan responds to claims about the effectiveness of prescribed medications. While patients often expect their drugs to work, a statement suggesting that only 20% of people b…

In today's podcast, we dive into President Trump's proposed tariffs on Canada, Mexico, and China and what these moves could mean for the life sciences industry. Tariffs, essentially taxes on imported…

The Wall Street Journal recently reported that China is aggressively targeting tech talent with lucrative job offers, offering triple the pay for positions in the chip-making industry, sparking conce…

The Trump administration’s new appointees, including Elon Musk, Dr. Marty Makary, Dr. Jay Bhattacharya, and Robert F. Kennedy Jr., promise a significant shift for the life sciences industry. Each bri…

We explore the rapidly evolving role of artificial intelligence (AI) in clinical trial research design. He discusses how AI is reshaping the pharmaceutical landscape and highlights key areas identifi…

We explore the emerging trend of patients bypassing traditional healthcare to obtain weight loss medications like Ozempic through unofficial channels and telehealth platforms. This underground moveme…

The FDA has stressed the critical importance of adequate supervision and monitoring in clinical trials to ensure they are conducted properly. A key figure responsible for this oversight is the Princi…

The Supreme Court's ruling in Loper Bright Enterprises v. Raimondo significantly impacts off-label marketing for pharmaceutical and medical device companies by challenging the FDA's authority to rest…

Artificial intelligence (AI) is transforming the life sciences sector, offering groundbreaking advancements in areas like drug discovery, clinical trials, and personalized patient care. As AI-driven …