Non-binding Guidance Ropes & Gray LLP

This installment of Ropes & Gray’s podcast series Non-binding Guidance explores recent regulatory developments related to the development and approval of oncology drugs in the U.S. and Europe. On this episode, hear from Ropes & Gray FDA regulatory partner Josh Oyster and head of the European life sciences practice Lincoln Tsang as they compare approaches from FDA and E.U. legislation, and discuss what that means for companies researching and developing new oncology products for a global market.

This episode of Ropes & Gray’s podcast series Non-binding Guidance examines the regulatory landscape for drug compounding and how it has evolved over the last 10 years since a 2012 nationwide fungal meningitis outbreak caused by contaminated drugs from the New England Compounding Center (NECC) rocked the industry and led to a legislative overhaul. Listen to FDA regulatory partner Josh Oyster and associate Becca Williams as they discuss the continuing ramifications of the outbreak, the challenges faced by FDA and drug compounders, the opportunities presented to investors in the life sciences industry, and key areas of regulatory development to watch.

This episode of Ropes & Gray’s podcast series Non-binding Guidance examines FDA’s final guidance on Clinical Decision Support (“CDS”) software, released in September, and its implications for the life sciences and health care industries. The final guidance represents a substantial change in FDA’s approach to CDS software regulation from the agency’s 2019 draft guidance and may prompt many software developers to reassess their CDS products in light of the new guidance. Join Ropes & Gray FDA regulatory partners Greg Levine and Kellie Combs and counsel Sarah Blankstein as they discuss FDA’s new CDS guidance and provide an overview of key changes, practical implications, and some of the challenges posed by the guidance.

Following the recent publication relating to continued global pressure on drug pricing, this episode of Ropes & Gray’s podcast series Non-binding Guidance focuses on the significant changes to global business and legal environments for drug pricing brought about by the COVID-19 pandemic and the impacts on the pharmaceutical supply chain and patient access to innovative cutting-edge therapies. Hear from Ropes & Gray’s head of European life sciences practice Lincoln Tsang and health care partner Margaux Hall as they discuss the trend of rising health care drug costs in the U.S. and the UK, significant implications of the Inflation Reduction Act and similar drug pricing policy in the countries outside the U.S., the increasing role of real-world evidence in decision making, and impacts from these changes across the U.S., Europe and worldwide.

This episode of Ropes & Gray’s podcast series Non-binding Guidance explores recent FDA guidance on recall readiness and other recall-related hot topics. In recent months, we have seen a trend of increased FDA inspection and enforcement activity as the impact from COVID-19 starts to lessen. Earlier this year, FDA also finalized guidance on the Initiation of Voluntary Recalls under 21 CFR Part 7, Subpart C, which explores FDA expectations regarding the process companies should already have in place ahead of a potential recall situation. Join Ropes & Gray FDA regulatory attorneys Josh Oyster and Beth Weinman as they provide a quick refresher on recalls and discuss the latest recall readiness suggestions from the Agency to help companies make decisions about how and when to recall their FDA-regulated products and how to involve FDA in that process. They also discuss FDA’s recent recall-related actions that invoked rarely-used legal authorities applicable to medical devices.

This episode of Ropes & Gray’s podcast series Non-binding Guidance continues our exploration of recent trends and updates on the use of real-world evidence in drug development. Join Ropes & Gray FDA regulatory attorneys, Kellie Combs and Sarah Blankstein, as they discuss four new draft guidance documents released by FDA in 2021 addressing the use of real-world evidence to support FDA decision-making on safety and effectiveness. Tune in to this episode to learn more about FDA’s current approach to real-world evidence, these recent draft guidances, and what we can expect from FDA looking ahead in 2022 and beyond.