13 episodes

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.

Non-binding Guidance Ropes & Gray LLP

    • Business
    • 3.7 • 3 Ratings

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.

    Non-binding Guidance: COVID-19 Vaccine Mandate Litigation

    Non-binding Guidance: COVID-19 Vaccine Mandate Litigation

    This installment of Ropes & Gray’s podcast series Non-binding Guidance explores the current legal challenges relating to vaccine mandates for public and private sector employers and institutions of all types. Join Greg Levine, head of Ropes & Gray’s life sciences regulatory and compliance practice, Megan Bisk, a partner in the employment, executive compensation, and employee benefits practice and lead of the employment specialty group, and David Peloquin, a partner in the health care practice group, as they discuss ongoing lawsuits related to COVID-19 vaccine mandates, the context of approvals through Emergency Use Authorizations, the PREP Act and data privacy implications, and employment law considerations.

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

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

    This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on The Defense Production Act (DPA), a wartime production law that gives the president a broad set of powers to influence and mobilize domestic industry in the interest of national defense, and its implications for life sciences companies. Over time, Congress has expanded the DPA’s scope to include civil crises resulting from national disasters, terrorist attacks, and other national emergencies—most recently, the COVID-19 pandemic. In this episode, Ropes & Gray life sciences regulatory & compliance attorneys Beth Weinman and Jessica Band discuss the history of the DPA, how it has been used during the COVID-19 pandemic, and what use we can expect to see going forward. The discussion also addresses the specific authorities conveyed by the DPA, how to respond to issuance of a priority-rated contract and the scope of such contracts, and what opportunities may be provided by the DPA for life sciences companies.

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

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

    This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA regulatory developments in the area of artificial intelligence (“AI”) and machine learning. AI and machine learning represent a rapidly growing frontier in digital health, with applications ranging from medical device software used for diagnostic and triaging applications to drug candidate selection to clinical trial design and interpretation. In this episode, FDA regulatory attorneys Kellie Combs, Greg Levine, and Sarah Blankstein explore the development and uptake of these technologies in response to the ongoing COVID-19 pandemic, FDA’s current regulatory landscape for these technologies, recent steps FDA has taken to update its regulatory approach to these tools in coordination with industry, and continuing trends in this area they expect to see through 2021.

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

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

    The eleventh installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on the current regulatory landscape surrounding the use of real-world evidence in drug development and the impact of the COVID -19 pandemic. Over the course of the COVID-19 pandemic, there has been an increase in reliance on real-world data and real-world evidence by FDA and other regulatory authorities, as well as industry. Innovative approaches and flexibility from the FDA during the pandemic ultimately may serve to accelerate the uptake of real-world evidence approaches post-pandemic. In this episode, FDA regulatory attorneys Kellie Combs and Sarah Blankstein discuss these recent developments and explore remaining impediments facing the use of real-world evidence and real-world data by regulators and industry stakeholders.

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

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

    The tenth installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on FDA regulation of COVID-19 diagnostic tests, with a particular focus on employee testing. In this episode, chair of Ropes & Gray’s FDA regulatory practice, Greg Levine, interviews Lauren Silvis, a former FDA official and currently Senior Vice President of External Affairs for Tempus, a clinical molecular technology company, to hear her input on the role employee testing can play in maintaining a safe workplace. Topics covered include the role of antibody tests, testing of asymptomatic persons, pooled sample testing, and evolving technologies such as Next Generation Sequencing (NGS). Prior to joining Tempus, Lauren spent a number of years at the FDA, first as deputy center director for policy in the agency's Center for Devices and Radiological Health, and subsequently as the FDA chief of staff, where she was responsible for overseeing the daily management of the agency and leading the agency's activities on major initiatives. Additionally, Lauren co-authored several reports and articles on COVID-19 – most recently, “How Businesses Can Keep Employees Safe From Coronavirus.”

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

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

    The eighth installment of Ropes & Gray’s podcast series Non-binding Guidance looks at SEC disclosure issues for life sciences companies. In this episode, Ropes & Gray partners Kellie Combs and Emily Oldshue discuss when to disclose, how to frame the disclosure, and how the responses to both of these questions are informed by SEC enforcement actions and securities litigation, as well as their experience working with life sciences companies in various stages of development. Emily and Kellie will dive into how to craft SEC disclosures involving a variety of FDA regulatory issues, such as clinical trial results, adverse findings from regulatory audits and inspections, and FDA interactions that occur during review of a pending application or post-market.

    • 13 min

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3 Ratings

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