This edition of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on one of the most fundamental concepts in FDA regulatory law: intended use. On August 2, FDA issued a final rule amending its drug and medical device regulations describing the types of evidence the Agency considers relevant to determining a product’s “intended use.” The new regulations just took effect on September 1. Join Kellie Combs, a partner in Ropes & Gray’s life sciences regulatory and compliance practice, Doug Hallward-Driemeier, a partner in the litigation & enforcement practice and head of the firm’s appellate & Supreme Court practice, and Josh Oyster, a senior associate in the life sciences regulatory and compliance practice group, as they discuss this final rule and what its implementation means for the drug and medical device industry.

Non-binding Guidance

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

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.

Non-binding Guidance: COVID-19 Vaccine Mandate Litigation

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.

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 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.

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

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.

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

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.”

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

The ninth installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on changes to the FDA regulation of certain products pursuant to the “Deemed to be a License” provision, also known as the transition provision, of the Biologics Price Competition and Innovation Act (BPCIA). On the transition date of March 23, 2020, around 90 insulin and other protein products currently regulated as drugs will be deemed to have Biologic License Applications and subject to regulation as biological products. In this episode, life sciences regulatory and compliance attorneys Kellie Combs and Deborah Cho are joined by Filko Prugo, chair of the life sciences IP litigation group, to discuss the transition provision and its anticipated impacts on regulatory exclusivity, patent litigation, and the biologics and biosimilars market.

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

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.

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

The seventh installment of Ropes & Gray’s podcast series, Non-binding Guidance, dives into the closely watched administrative law case, Kisor v. Wilkie. This Supreme Court case addresses the continued validity of the doctrine articulated in the 1997 Supreme Court case Auer v. Robbins, regarding judicial deference to federal administrative agency interpretations of their own regulations. In this episode, Ropes & Gray partner Greg Levine interviews his colleagues, Doug Hallward-Driemeier and Beth Weinman, about the factual background, opinions, and potential implications of Kisor, with particular emphasis on its significance for FDA-regulated life sciences companies seeking to challenge FDA or other federal agency regulatory interpretations. Among other things, Beth and Doug discuss the signals the Kisor case sends about the future of Chevron deference, which addresses the related question of judicial deference to agency interpretations of statutes. Tune in to this discussion to learn about key takeaways from the Supreme Court’s Kisor ruling and its potential impact on FDA-regulated companies.

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

The sixth installment of Ropes & Gray’s podcast series, Non-binding Guidance, continues our two-part discussion on FDA expedited review programs. In this episode, Ropes & Gray lawyer Kellie Combs interviews her partner Greg Levine, who provides an overview of FDA’s new Breakthrough Devices Program. This program, which was finalized in late 2018, aims to expedite the development and FDA premarket review of devices used in the treatment or diagnosis of serious or life-threatening conditions. The Breakthrough Devices Program provides a variety of benefits to manufacturers, including priority review and more frequent and efficient feedback from FDA during the submission and review process, so that devices receiving breakthrough designation can reach the patients who need them quickly and efficiently. In this episode, Greg dives into the program’s eligibility criteria, benefits, when to apply, and some of the practical considerations associated with the program. Additionally, Kellie and Greg discuss recent trends and developments affecting breakthrough devices and provide examples of devices that have recently received breakthrough device designation or that were approved or cleared as breakthrough devices. Tune in to this discussion to learn more about the program and its impact on the medical device industry.

Non-binding Guidance: Breakthrough Devices Program

The fifth installment of Ropes & Gray’s podcast series, Non-binding Guidance, is the first part of a two-episode discussion of FDA expedited review programs. In this episode, Ropes & Gray lawyer Greg Levine interviews his partner Kellie Combs, who provides an overview of the four expedited review programs for drugs and biologics: the Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval programs. These programs, which are broadly intended to address unmet needs in the treatment of serious or life-threatening conditions for which existing therapies are insufficient, are associated with significant benefits for manufacturers, such as earlier and more frequent FDA interactions, streamlined clinical development requirements, and a shorter FDA review clock—all of which may accelerate time to market and improve the bottom line. In this episode, Kellie discusses the eligibility criteria and benefits associated with each program, and describes timing and other practical issues for product manufacturers to consider. Tune in to this discussion to learn more about the expedited review programs and how to secure the benefits. Next week, we’ll release the second episode of this two-part series, which will focus on the Breakthrough Devices Program. Please stay tuned.

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

The fourth installment of Ropes & Gray’s podcast series, Non-binding Guidance, dives into the use of real-world evidence in drug development. In this episode, Ropes & Gray lawyers Kellie Combs and Sarah Blankstein discuss FDA’s current thinking on real-world evidence and how industry has been using real-world evidence studies in FDA submissions, as well as with payors and in product promotion. The speakers highlight key takeaways from FDA’s framework for real-world evidence, issued in December 2018, including the types of data sources and study designs that FDA considers to be “real-world,” and the Agency’s approach to assessing real-world evidence intended to support a determination of effectiveness. Additionally, our presenters discuss highlights from FDA and the Duke-Margolis Center’s public workshop on real-world evidence, which took place on July 11-12. Tune in to this discussion to learn more about FDA’s approach to real-world evidence, the impact on industry, and what companies should be thinking about in this space.

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

The third installment of Ropes & Gray’s podcast series, Non-binding Guidance, highlights two recent federal district court decisions implicating enforcement efforts in the stem cell and compounding arenas. This episode, Ropes & Gray lawyers Greg Levine and Beth Weinman first explore the D.C. District Court’s decision to grant summary judgment to FDA in its efforts to enjoin a Florida clinic from administering unapproved adipose derived stem cell injections to patients to treat a number of serious diseases. Next they address a loss for the government in the decision by the Federal District Court for the District of Massachusetts to overturn the convictions of two former employees of the New England Compounding Center (NECC) for conspiracy to defraud FDA, on the basis of legal impossibility. Tune in to this discussion to learn more about these federal district court decisions, their impact on the industry, and how the Agency will move forward as a result of these findings.

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

The second installment of Ropes & Gray’s new podcast series, Non-binding Guidance, addresses the departure of former FDA Commissioner Scott Gottlieb, who resigned from his position last month. During his time at FDA, Commissioner Gottlieb employed an ambitious policy agenda, taking significant steps to combat the opioid crisis, improve access to generic drugs and biosimilars, confront the use of e-cigarettes by minors, and more. In this episode, Ropes & Gray lawyers Greg Levine, Kellie Combs, and Beth Weinman explore several areas of uncertainty that remain in the wake of Dr. Gottlieb’s resignation: the regulation of laboratory developed tests, dietary supplements, and off-label communications. Tune in to this discussion to learn more about the unfinished business of the Gottlieb administration, the impact of his resignation, and how the agency will move forward under Acting Commissioner Ned Sharpless.

Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business

Ropes & Gray’s new podcast series, Non-binding Guidance, highlights FDA regulatory developments and trends affecting the life sciences industry. In this inaugural episode, Ropes & Gray lawyers Al Cacozza, Sarah Blankstein and Joshua Oyster discuss how the FDA is currently regulating products containing cannabidiol, or CBD, and what to expect from FDA and Congress in the wake of FDA Commissioner Scott Gottlieb’s surprise resignation this month. The 2018 Farm Bill, signed into law last December, legalized hemp and its non-psychoactive ingredient CBD and distinguished both from marijuana, which is still considered by the federal government to be an illegal narcotic. But the Farm Bill left a cloud of uncertainty hanging over the emerging CBD industry because it expressly allowed FDA to continue unchanged its oversight and regulation of CBD products. Tune in to this lively discussion of the repercussions of the Farm Bill, how the FDA and state agencies are responding, and what investors and other stakeholders should know.

Non-binding Guidance: FDA’s Regulation of Products Containing CBD

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.

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Non-binding Guidance

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