This is a free preview of a paid episode. To hear more, visit <a href="https://naveenagarwalphd.substack.com?utm_medium=podcast&utm_campaign=CTA_7">naveenagarwalphd.substack.com</a> Summary“More importantly than ever, a good product development and risk-based approach is going to be critical.” In this episode of the <a target="_blank" href="https://naveenagarwalphd.substack.com/podcast">Let's Talk Risk Podcast</a>, Naveen Agarwal and Michael Nilo discuss the current state of the FDA amidst significant staff cuts and organizational chaos. They explore the implications for regulatory affairs professionals, t…

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “More importantly than ever, a good product development and risk-based approach is going to be critical.” In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Michael Nilo discuss the current state of the FDA amidst significant staff cuts and organizational chaos. They explore the implications for regulatory affairs professionals, t…

This is a free preview of a paid episode. To hear more, visit <a href="https://naveenagarwalphd.substack.com?utm_medium=podcast&amp;utm_campaign=CTA_7" rel="noopener noreferrer">naveenagarwalphd.substack.com</a> Summary“More importantly than ever, a good product development and risk-based approach is going to be critical.” In this episode of the <a href="https://naveenagarwalphd.substack.com/podcast" rel="noopener noreferrer">Let's Talk Risk Podcast</a>, Naveen Agarwal and Michael Nilo discuss the current state of the FDA amidst significant staff cuts and organizational chaos. They explore the implications for regulatory affairs professionals, t…

LTR 97: Surviving chaos and uncertainty at the FDA

Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together! <a href="https://naveenagarwalphd.substack.com?utm_medium=podcast">naveenagarwalphd.substack.com</a>

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Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together! naveenagarwalphd.substack.com

Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together! <a href="https://naveenagarwalphd.substack.com?utm_medium=podcast" rel="noopener noreferrer">naveenagarwalphd.substack.com</a>

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LTR 97: Surviving chaos and uncertainty at the FDA

LTR 97: Surviving chaos and uncertainty at the FDA

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