Darshan Kulkarni

DarshanTalks Podcast

Science EN ↓ 356 episodes

Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do. We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn ab...

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Author

Darshan Kulkarni

Episodes

Research Fraudster Banned by the FDA 28.09.2023 0:55

Send us Fan Mail 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 organiza...

How does CTP regulate tobacco? | Micah Berman 26.09.2023 40:24

Send us Fan Mail The FDA's Center for Tobacco Products (CTP) was created in 2009 to regulate tobacco products. Micah Berman worked at CTP from 2011-2012. He discusses the CTP's evolution in the past decade and shares insights from his recent article published in the New England Journal of Medicine. We discussed the following: When was Micah a part of CTP? - 0:58 - 1:27 What was the vi...

60 second reveal: 3 Regulatory authorities that can make or break your pharma or device sale 24.09.2023 0:51

Send us Fan Mail Darshan Kulkarni emphasizes that companies considering #acquisitions must be ready for scrutiny from multiple agencies: FDA, FTC, DOJ, and OIG. FDA examines various aspects like manufacturing, clinical research, pharmacovigilance, advertising, and distribution. FTC now addresses advertising and antitrust concerns. DOJ concentrates on corporate compliance. Is your organization wel...

Maximizing FDA meetings: Getting the best out of every encounter | Ashley Preston 23.09.2023 28:49

Send us Fan Mail In this episode, the focus is on planning #FDA meetings and the significance of pre-IND meetings. We discuss how pre-IND meetings are crucial for identifying and addressing any roadblocks or gaps in the preclinical program before the actual filing. By doing so, potential delays or complications during the clinical trial phase can be mitigated. The discussion also includes insight...

The role of decentralized trials in the traditional landscape | Isaac Rodriguez- Chavez 02.09.2023 17:53

Send us Fan Mail Isaac Rodriguez-Chavez discusses the role and the significance of the Decentralized Clinical Trials guidance. We discuss the following: What are decentralized clinical trials? - 2:05- 4:25 What factors led to the rise of decentralized trials? – 4:26- 10:58 What is the role of decentralized clinical trials?- 10:59- 14:36 What is the process of FDA to develop a guidance?- 14:4...

The Essential Guide to 7 Types of Clinical Trial Agreements 27.08.2023 33:24

Send us Fan Mail Istvan Fekete and Darshan Kulkarni discuss the 7 types of clinical trial agreements (CTAs). CTAs Explored Include: Industry-Sponsored Trials, Phase Four and Post-Market Studies, Registry Studies, Federally Funded Studies, Drug and Device Studies, Consortium Studies, Investigator-Initiated Studies: We discuss the potential risks of seeding trials, and the need for both sp...