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Firm News 1 result

Firm News | 4 min read | 01.16.24

Respected Healthcare Regulatory and Privacy and Cybersecurity Team Joins Crowell

New York – January 16, 2024: Linda Malek, Jason Johnson and Blaze Waleski are joining Crowell & Moring’s Health Care and Privacy & Cybersecurity groups and will be based in the New York office.
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Client Alerts 11 results

Client Alert | 3 min read | 06.26.25

FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material.
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Client Alert | 3 min read | 05.07.25

NIH Continues Grant Awards Overhaul With New Limitations on Foreign Subawards

On May 1, the NIH issued an update on its grants policy, establishing a “new award structure” that would prohibit foreign subawards from being nested under the parent grant, replacing them with direct awards linked to a prime award. Effective immediately, NIH will no longer issue awards that include a subaward to a foreign entity until the new structure is implemented. The notice did not limit this new structure for foreign recipients to any particular jurisdiction, potentially impacting a wide range of grants and limiting international collaboration with U.S. researchers through the subaward model.
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Client Alert | 5 min read | 03.28.25

HHS Announces “Dramatic Restructuring”

On March 27, 2025, HHS announced a “dramatic restructuring” of its various agencies and offices in accordance with President Trump's Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” HHS also published a Fact Sheet.
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Press Coverage 7 results

Publications 2 results

Events 2 results

Event | 02.25.25, 5:00 PM EST - 8:00 PM EST

Charting a Path for Compliance in Life Sciences

Join us for an interactive and educational event tailored for biotech leaders seeking to ensure security compliance while leveraging the power of Amazon Web Services (AWS). This session will dive into the critical elements of designing secure, scalable, and compliant systems for biotech operations, from research and development to clinical trials and beyond.
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Event | 03.13.24 - 03.14.24

Clinical Trials Masterclass

Crowell & Moring Partners Linda Malek and Jason Johnson, members of the firm's Health Care and Privacy & Cybersecurity Groups, will be speaking at Entrepreneurship Lab Bio and Health Tech NYC’s Clinical Trials Masterclass , taking place on March 13-14 in New York, NY.

They will both speak on "Best Practices in Recruiting for Health Equity: Designing a Successful Protocol for Recruitment" at 9:45 a.m. EST. Linda will also speak on "Future of Clinical Trials" and "Presentation of Attendee Clinical Trial Site Checklist: Feedback from Professionals", which will take place at 8:40 a.m. EST and 10:50 a.m. EST, respectively. Jason's talk, "Presentation of Attendee Clinical Trials with focus on recruiting," will begin at 10:50 a.m. EST. 

Webinars 1 result

Webinar | 06.26.25 - 09.25.25

HOOPS 2025

We invite you to join the Health Care Group at Crowell for our Health Care Opportunities, Oversight, Policy, and Strategy (HOOPS) Summer Webinar Series. 

Speaking Engagements 2 results

Blog Posts 8 results

Blog Post | 10.17.24

FDA Calls Out a Migraine TV Ad for Misleading Viewers

Crowell Health Solution’s Trends in Transformation

Podcasts 3 results

Podcast | 03.24.25

&Motion: Lessons From the CPPA’s Settlement with a Connected Vehicle Manufacturer

On March 12, the California Consumer Privacy Protection Agency announced it had entered into a settlement with Honda totaling more than $630,000 to resolve the Agency’s claims that Honda violated the California Consumer Privacy Act. The investigation came out of the Agency’s review of vehicles with embedded features such as location sharing, smartphone integration, and cameras.
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Podcast | 01.08.25

&Motion - A.I. in the Transportation Industry: An Intro to the Tech and the Issues

&Motion sits down with Crowell’s own Jason Johnson and Neda Shaheen to discuss the basics of A.I., what Generative A.I. means, how these systems learn, and the uses of A.I. in, and risks for, the transportation space. To view the full presentation, please click here.
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Podcast | 06.14.24

Payers, Providers, and Patients – Oh My!: AI in Health Care Series, Part 1: AI Use in Clinical Research Institutions

In this episode, hosts Megan Beaver and Savanna Williams talk to Jason Johnson and Linda Malek about the evolving regulatory landscape related to artificial intelligence (AI) in health care. In particular, Jason and Linda discuss the use of AI by organizations engaged in clinical research including key issues and emerging themes in this field.
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