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Jan 15, 2025 | 
jdsupra.com | Melissa Bianchi |Michael Druckman |Melissa Levitt
The U.S. Department of Justice (DOJ) has finalized its rule on “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” which restricts data brokerage transactions involving access to bulk U.S. sensitive personal data and transactions involving access to bulk human genomic data (now expanded to certain ‘omic data) or biospecimens from which such data can be derived.
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Oct 2, 2024 | 
jdsupra.com | Michael Druckman |Meredith Manning |Bryan Walsh
FDA’s regulations set forth criteria for determining when particular products are regulated merely as transplanted human cells or tissues subject only to the authority of Section 361 of the Public Health Service Act (PHSA) to prevent the transmission of communicable diseases. Such products, referred to as “361 HCT/Ps” or 361 products, may be sold without prior FDA review.
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Jun 4, 2024 | 
jdsupra.com | Robert Church |Michael Druckman |Ashley Grey
FDA developed the new platform technology designation program draft guidance to fulfill its requirement under Section 506K(b) of the Federal Food, Drug, and Cosmetic Act (FDCA), codified at 21 USC 356k, which was passed as part of the “PREVENT Pandemics Act” in December 2022.
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May 22, 2024 | 
jdsupra.com | Michael Druckman |Yetunde Fadahunsi
FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in the last few years and the unprecedented approval, on the same day in 2023, of a novel gene editing product and another gene therapy product for sickle cell disease.
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May 22, 2024 | 
jdsupra.com | Tim Bergreen |Michael Druckman |Ajay Kuntamukkala
While the landscape continues to evolve rapidly, there are steps that life sciences companies – particularly cell, tissue, and gene therapy (CTGT) and other companies engaged in complex biotechnology manufacturing – should consider taking now to avoid unintended and potentially serious consequences if (/when) the pending legislation is enacted.
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Mar 15, 2024 | 
jdsupra.com | Michael Druckman |Katie Kramer |Bryan Walsh
Changes from the draft guidance:In January 2024, FDA published the final guidance “Human Gene Therapy Products Incorporating Human Genome Editing,” finalizing a March 2022 draft guidance of the same name.
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Feb 1, 2024 | 
jdsupra.com | Barry Burgdorf |Michael Druckman |Daniel Garcia
Innovative technologies are reshaping every industry, presenting new business cases and changing our daily lives. These technologies are hyper-connecting the world and offering new ways to interact. Particularly in the Space and Satellite arena, technology is ever-evolving, expanding, and combining in ways never before contemplated.
Please see full publication below for more information.
Download PDF
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Jan 8, 2024 | 
lemonde.fr | Michael Druckman |Thibault Muzergues
Débats Guerre en Ukraine Les politistes Michael Druckman et Thibault Muzergues, du think tank International Republican Institute, constatent que l’Occident est moins empressé à aider l’Ukraine. Ce pays résiste pourtant toujours à l’offensive russe et garde le regard tourné vers l’Ouest. Temps de Lecture 3 min.
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Dec 7, 2023 | 
jdsupra.com | Sanchita Bose |Michael Druckman |Kristin Zielinski Duggan
The proposed rules, Rule 1 and Rule 2, would implement classification of currently unclassified, pre-amendments wound dressings and liquid wound washes containing antimicrobials and/or other chemicals. Such products are currently regulated through the 510(k) pathway. The proposed classification is informed largely by feedback taken from previous FDA panel meetings held in 2005 and 2016, which we summarized online here.
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Nov 22, 2023 | 
kyivindependent.com | Michael Druckman |Zachary Popovich
Ukrainian President Volodymyr Zelensky made headlines when he confirmed his belief that general elections should be postponed until after Ukraine wins the war. Despite some calls from Western allies to field elections sooner rather than later, polling shows that a majority of Ukrainians agree with Zelensky’s assessment that the country must remain laser-focused on prevailing in the fight against Russia.
