On this episode, I was joined by Darshan Kulkarni, of

– Free Speech and Promotional Compliance

– Misbranding

– Regulatory vs. Legal Compliance

– From Congress to the FDA – the flow from legislation to regulations

– Sunshine Act

Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and speaker, who takes a holistic approach to the healthcare and life sciences industries. Through the lens of patient centricity, including the underlying concepts of privacy, transparency, innovation, and access, Darshan looks at the broader implementation of programs by life sciences companies and healthcare professionals. With a background in creating companies, developing products, and helping guide finished products through the approval process where he has sold products as a pharmacist, Darshan has a unique perspective on how the pharmaceutical, regulatory, and life sciences industries intersect and function.