Non-binding Guidance: FDA’s Intended Use Final Rule
This edition of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on one of the most fundamental concepts in FDA regulatory law: intended u...
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.
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 a...
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 giv...
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 ...
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 re...
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 particula...
Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
The ninth installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on changes to the FDA regulation of certain products pursuant to...
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 episo...
Non-binding Guidance: A Discussion of Kisor v. Wilkie
The seventh installment of Ropes & Gray’s podcast series, Non-binding Guidance, dives into the closely watched administrative law case, Kisor v. Wilki...
Non-binding Guidance: Breakthrough Devices Program
The sixth installment of Ropes & Gray’s podcast series, Non-binding Guidance, continues our two-part discussion on FDA expedited review programs. In t...