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Jan 14, 2025 | 
mondaq.com | Linda A. Malek |Jason Johnson |Stephen Holland
On January 6, with increased attention and scrutiny frompatients, providers, developers, and payors on the acceleratedapproval pathway for drugs, the Food and Drug Administration (FDA)released new draft guidance for industry on what it meansfor a drug's confirmatory trial to be "underway"under section 506(c) of the Federal Food, Drug, and CosmeticAct.
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Nov 12, 2024 | 
mondaq.com | Jodi G. Daniel |Linda A. Malek |Jason Johnson |Evan Y. Chuck
On October 29, 2024, the Department of Justice (DOJ) published a
Notice of Proposed Rulemaking (NPRM) to implement
Executive Order 14117 "Preventing Access to Americans'
Bulk Sensitive Personal Data and United States Government-Related
Data by Countries of Concern" (the E.O.).
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Nov 5, 2024 | 
mondaq.com | Jennie Wang VonCannon |Linda A. Malek |Garylene Javier |Anna Z. Saber
CM
Crowell & Moring LLP
More
Our founders aspired to create a different kind of law firm when they launched Crowell & Moring in 1979. From those bold beginnings, our mission has been to provide our clients with the best services of any law firm in the world through a spirit of trust, respect, cooperation, collaboration, and a commitment to giving back to the communities around us.
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Oct 29, 2024 | 
today.westlaw.com | Jodi G. Daniel |Linda A. Malek |Jason Johnson |Evan Y. Chuck
(December 06, 2024) - Jodi Daniel, Linda Malek, Jason Johnson and Evan Chuck of Crowell & Moring discuss a proposed rule to implement President Joe Biden's executive order: "Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern." On October 29, 2024, the Department of Justice (DOJ) published a Notice of Proposed Rulemaking (NPRM, https://bit.ly/4i6HemQ) to implement Executive Order 14117 (https://bit.ly/3ZaeiBX)...
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Oct 24, 2024 | 
today.westlaw.com | Jason Johnson |Linda A. Malek |Eunice Lalanne
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Oct 23, 2024 | 
thetechstreetnow.com | Marianne Kolbasuk McGee |Linda A. Malek
7 minutes ago bankinfosecurity Attorney Linda Malek of Crowell & Moring on Top Third-Party Cyber Concerns Marianne Kolbasuk McGee (HealthInfoSec) • October 23, 2024 12 Minutes It's crucial for healthcare sector organizations to vet their artificial intelligence tech vendors in the same robust way they scrutinize the privacy and security practices of all their other third-party suppliers, said attorney Linda Malek, partner at law firm Crowell & Moring.
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Sep 2, 2024 | 
mondaq.com | Michael G. Gruden |Linda A. Malek |Eric Ransom |Neda M. Shaheen
On August 21, 2024, the National Institute of Standards and
Technology (NIST) released the Second Public Draft of Digital Identity Guidelines
(hereinafter, "Draft Guidelines") for final review. The Draft Guidelines introduce potentially notable requirements for
government contractors using artificial intelligence (AI) systems. Among the most significant draft requirements are those related to
the disclosure and transparency of AI and machine learning (ML).
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Aug 7, 2024 | 
today.westlaw.com | Linda A. Malek |Jason Johnson |Stephen Holland
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Jul 19, 2024 | 
law360.com | Linda A. Malek |Jason Johnson |Stephen Holland
By Linda Malek, Jason Johnson and Stephen Holland (July 19, 2024, 4:35 PM EDT) -- On June 26, the U.S. Food and Drug Administration released draft guidance on clinical trial diversity action plans, outlining new required elements of drug and device submissions, updating recommendations for sponsors, and setting in motion the timeline for potential enforcement from the FDA.... Law360 is on it, so you are, too.
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Jul 19, 2024 | 
law360.co.uk | Linda A. Malek |Jason Johnson |Stephen Holland
By Linda Malek, Jason Johnson and Stephen Holland (July 19, 2024, 4:35 PM EDT) -- On June 26, the U.S. Food and Drug Administration released draft guidance on clinical trial diversity action plans, outlining new required elements of drug and device submissions, updating recommendations for sponsors, and setting in motion the timeline for potential enforcement from the FDA....
