DarshanTalks Podcast

We discuss biotech fraud and the pivotal role of a comprehensive legal strategy, especially one that integrates FDA regulatory lawyers. A biotech CEO's admission to securities fraud, misleading inves…

In December 2023, two US senators raised concerns, urging the government to scrutinize the FDA's oversight of medical device recalls, notably amidst the ongoing Phillips Respironics recall.

Join us to…

In a congruency review, the primary objective is to ensure alignment across various elements in clinical research. The initial crucial step involves accurately analyzing Medicare coverage, determinin…

We delve into the growing allure of clinical research sites and organizations for private equity firms. Backed by BPOC, these investments signify more than just single business deals; they are a test…

In this episode, the focus is on navigating the complex landscape of off-label information sharing, exploring legal aspects in the context of the life sciences industry. Sponsored by the Kulkarni Law…

Darshan discussed crucial updates to the Department of Justice's (DOJ) corporate enforcement policies, particularly impacting FDA-regulated industries like pharmaceuticals and medical devices. The DO…

In this podcast, we discuss the legal and regulatory factors for securing approval for your digital speaker program. Key points include 
prioritizing audience privacy, 
adhering to FTC disclosure regul…

FDA Issues Crucial Guidance on Prescription Drug Software! 

Darshan Kulkarni delves into the FDA's recent guidance on prescription drug-related software. The discussion revolves around three key consi…

Insider Exposes crucial missing step in Clinical Trial Agreements activation - Congruency Review Details Revealed!

In the clinical trial agreement activation pathway, the journey involves several crit…

Accelerate your digital speaker program review with these 5 game-changing strategies:
 Policy Creation & Training
 Pre-reviews
 AI-based Reviews
  Modular Reviews
Applying Quality Learnings Across the Pro…

Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company's experience and expertise in a specific disease state…

We discuss five key legal and regulatory considerations for a digital sales force:
Starting with updates to the Physician Payment Sunshine Act, emphasizing the need for training, robust internal cont…

We explore the crucial aspects outlined by the FTC regarding comparative claims in drug and device advertising. 
the paramount importance of transparency in promotional efforts,
the pitfalls associated…

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 Option (CRACO). While the concept seems promising,…

In this podcast, we discuss artificial intelligence (AI) and machine learning, exploring their pivotal roles in drug development. AI, a fusion of computer science, statistics, and engineering, employ…

The National Advertising Division (NAD) recently examined a TV ad by Bravecto, comparing its flea and tick prevention product with NexGard's. The ad suggested Bravecto's greater effectiveness, disput…

In this podcast, five crucial considerations for obtaining approval for a digital speaker program are discussed:

1. Privacy Compliance:
   - Consider where audience data will be stored and ensure compl…

he recently issued FDA guidance mandates manufacturers, packers, and distributors to adhere to new standards, emphasizing mandatory product and facility registrations, creation of safety substantiati…

In this podcast episode, we'll uncover five strategies to expedite the digital promotion review process. Starting with
1. Policy creation and training emphasizes aligning policies across platforms, in…

Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices for selecting a predicate device when preparing a 5…