Non-binding Guidance

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A Ropes & Gray (RopesTalk) podcast series, focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.

Ropes & Gray LLP


    • Oct 13, 2022 LATEST EPISODE
    • infrequent NEW EPISODES
    • 19m AVG DURATION
    • 58 EPISODES


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    Latest episodes from Non-binding Guidance

    Non-binding Guidance: Continued Global Pressure on Drug Pricing & Reimbursement and the Next Frontiers for Effective Market Access

    Play Episode Listen Later Oct 13, 2022 22:24


    Non-binding Guidance: Continued Global Pressure on Drug Pricing & Reimbursement and the Next Frontiers for Effective Market Access

    Play Episode Listen Later Oct 13, 2022 22:24


    Non-binding Guidance: Continued Global Pressure on Drug Pricing & Reimbursement and the Next Frontiers for Effective Market Access

    Play Episode Listen Later Oct 13, 2022 22:24


    Non-binding Guidance: A Recall Readiness Rundown and Recent FDA Actions

    Play Episode Listen Later May 19, 2022 21:40


    Non-binding Guidance: A Recall Readiness Rundown and Recent FDA Actions

    Play Episode Listen Later May 19, 2022 21:40


    Non-binding Guidance: A Recall Readiness Rundown and Recent FDA Actions

    Play Episode Listen Later May 19, 2022 21:40


    Non-binding Guidance: Real-World Evidence in Drug Development

    Play Episode Listen Later Mar 30, 2022 17:34


    Non-binding Guidance: Real-World Evidence in Drug Development

    Play Episode Listen Later Mar 30, 2022 17:34


    Non-binding Guidance: Real-World Evidence in Drug Development

    Play Episode Listen Later Mar 30, 2022 17:34


    Non-binding Guidance: Recent Developments in FDA Inspection Policy and Implications for Drug and Device Manufacturers

    Play Episode Listen Later Jan 6, 2022 22:07


    Non-binding Guidance: Recent Developments in FDA Inspection Policy and Implications for Drug and Device Manufacturers

    Play Episode Listen Later Jan 6, 2022 22:07


    Non-binding Guidance: Recent Developments in FDA Inspection Policy and Implications for Drug and Device Manufacturers

    Play Episode Listen Later Jan 6, 2022 22:07


    Non-binding Guidance: Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule

    Play Episode Listen Later Nov 8, 2021 16:32


    Non-binding Guidance: Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule

    Play Episode Listen Later Nov 8, 2021 16:32


    Non-binding Guidance: Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule

    Play Episode Listen Later Nov 8, 2021 16:32


    Non-binding Guidance: FDA's Intended Use Final Rule

    Play Episode Listen Later Sep 21, 2021 24:17


    Non-binding Guidance: FDA's Intended Use Final Rule

    Play Episode Listen Later Sep 21, 2021 24:17


    Non-binding Guidance: FDA's Intended Use Final Rule

    Play Episode Listen Later Sep 21, 2021 24:17


    Non-binding Guidance: COVID-19 Vaccine Mandate Litigation

    Play Episode Listen Later Jul 29, 2021 26:14


    Non-binding Guidance: COVID-19 Vaccine Mandate Litigation

    Play Episode Listen Later Jul 29, 2021 26:14


    Non-binding Guidance: COVID-19 Vaccine Mandate Litigation

    Play Episode Listen Later Jul 29, 2021 26:14


    Non-binding Guidance: The Defense Production Act and the COVID-19 Pandemic

    Play Episode Listen Later May 27, 2021 18:37


    Non-binding Guidance: The Defense Production Act and the COVID-19 Pandemic

    Play Episode Listen Later May 27, 2021 18:37


    Non-binding Guidance: The Defense Production Act and the COVID-19 Pandemic

    Play Episode Listen Later May 27, 2021 18:37


    Non-binding Guidance: FDA Regulatory Developments in AI and Machine Learning

    Play Episode Listen Later Mar 3, 2021 18:14


    Non-binding Guidance: FDA Regulatory Developments in AI and Machine Learning

    Play Episode Listen Later Mar 3, 2021 18:14


    Non-binding Guidance: FDA Regulatory Developments in AI and Machine Learning

    Play Episode Listen Later Mar 3, 2021 18:14


    Non-binding Guidance: Real-World Evidence in Drug Development and the Impact of the COVID-19 Pandemic

    Play Episode Listen Later Sep 30, 2020 17:31


    Non-binding Guidance: Real-World Evidence in Drug Development and the Impact of the COVID-19 Pandemic

    Play Episode Listen Later Sep 30, 2020 17:31


    Non-binding Guidance: Real-World Evidence in Drug Development and the Impact of the COVID-19 Pandemic

    Play Episode Listen Later Sep 30, 2020 17:31


    Non-binding Guidance: FDA Regulation of COVID-19 Diagnostic Tests and “Return to Work”

    Play Episode Listen Later Jul 21, 2020 23:49


    Non-binding Guidance: FDA Regulation of COVID-19 Diagnostic Tests and “Return to Work”

    Play Episode Listen Later Jul 21, 2020 23:49


    Non-binding Guidance: FDA Regulation of COVID-19 Diagnostic Tests and “Return to Work”

    Play Episode Listen Later Jul 21, 2020 23:49


    Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act

    Play Episode Listen Later Mar 5, 2020 15:49


    Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies

    Play Episode Listen Later Jan 9, 2020 13:28


    Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies

    Play Episode Listen Later Jan 9, 2020 13:28


    Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies

    Play Episode Listen Later Jan 9, 2020 13:28


    Non-binding Guidance: A Discussion of Kisor v. Wilkie

    Play Episode Listen Later Nov 12, 2019 27:06


    Non-binding Guidance: A Discussion of Kisor v. Wilkie

    Play Episode Listen Later Nov 12, 2019 27:06


    Non-binding Guidance: A Discussion of Kisor v. Wilkie

    Play Episode Listen Later Nov 12, 2019 27:06


    Non-binding Guidance: Breakthrough Devices Program

    Play Episode Listen Later Sep 12, 2019 15:51


    Non-binding Guidance: Breakthrough Devices Program

    Play Episode Listen Later Sep 12, 2019 15:51


    Non-binding Guidance: Breakthrough Devices Program

    Play Episode Listen Later Sep 12, 2019 15:51


    Non-binding Guidance: Expedited Review Programs for Drugs and Biologics

    Play Episode Listen Later Sep 5, 2019 13:10


    Non-binding Guidance: Expedited Review Programs for Drugs and Biologics

    Play Episode Listen Later Sep 5, 2019 13:10


    Non-binding Guidance: Expedited Review Programs for Drugs and Biologics

    Play Episode Listen Later Sep 5, 2019 13:10


    Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions

    Play Episode Listen Later Aug 12, 2019 16:19


    Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions

    Play Episode Listen Later Aug 12, 2019 16:19


    Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions

    Play Episode Listen Later Aug 12, 2019 16:19


    Non-binding Guidance: Examining FDA's Enforcement Authority Over Stem Cell Clinics and Compounders

    Play Episode Listen Later Jun 28, 2019 25:12


    Non-binding Guidance: Examining FDA's Enforcement Authority Over Stem Cell Clinics and Compounders

    Play Episode Listen Later Jun 28, 2019 25:12


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