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10 Jan 2024, 11:11 am
The first is that regulatory authorities and patient groups maintain that, legally, the standards of accelerated approval are the same as standard approval. [read post]
10 Jan 2024, 10:52 am
However, regulated entities do not include review websites and “Comments incidental to content posted by an established and widely recognized media outlet, the primary purpose of which is to report news and current events. [read post]
10 Jan 2024, 8:41 am
Companies should carefully review their marketing campaigns to ensure compliance with the new Act, especially given that, in its first year, it remains to be seen how courts will interpret the term “automated system” and whether private plaintiffs will jump at the chance to litigate against unprepared companies. [read post]
9 Jan 2024, 10:00 pm
In an article for The Review of Securities & Commodities Regulation , partner Christine Schleppegrell and associate Thomas Crociata observed that while most of the private fund industry is still navigating the nuances of the new rules, it is clear that its effects will be global. [read post]
9 Jan 2024, 10:00 pm
In an article for The Review of Securities & Commodities Regulation , partner Christine Schleppegrell and associate Thomas Crociata observed that while most of the private fund industry is still navigating the nuances of the new rules, it is clear that its effects will be global. [read post]
9 Jan 2024, 10:00 pm
In an article for The Review of Securities & Commodities Regulation , partner Christine Schleppegrell and associate Thomas Crociata observed that while most of the private fund industry is still navigating the nuances of the new rules, it is clear that its effects will be global. [read post]
9 Jan 2024, 10:00 pm
In an article for The Review of Securities & Commodities Regulation , partner Christine Schleppegrell and associate Thomas Crociata observed that while most of the private fund industry is still navigating the nuances of the new rules, it is clear that its effects will be global. [read post]
9 Jan 2024, 10:00 pm
In an article for The Review of Securities & Commodities Regulation , partner Christine Schleppegrell and associate Thomas Crociata observed that while most of the private fund industry is still navigating the nuances of the new rules, it is clear that its effects will be global. [read post]
9 Jan 2024, 10:00 pm
In an article for The Review of Securities & Commodities Regulation , partner Christine Schleppegrell and associate Thomas Crociata observed that while most of the private fund industry is still navigating the nuances of the new rules, it is clear that its effects will be global. [read post]
9 Jan 2024, 9:05 pm
Bekker, Flores, and Sinha conclude that increasing FDA’s authority is necessary to protect consumers, but it is up to consumers to decide whether they value unrestricted access to supplements over safety.The post FDA’s Minimal Authority over Dietary Supplements first appeared on The Regulatory Review. [read post]
9 Jan 2024, 2:26 pm
Under the new rule OCR handles complaints on statutory violations, coordinates enforcement actions with DOJ or other relevant departments, conducts compliance reviews, and provide best practice guidance on notice provisions. [read post]
9 Jan 2024, 10:10 am
Read now » Related Content Bank Partnerships with Fintech Companies Review this practice note for a comprehensive outline of the banking regulations applicable to the Bank-Fintech partnership model, regulatory considerations, and implications emerging from this new business model. [read post]
9 Jan 2024, 9:00 am
After review and public comment, the AG listed the Global Privacy Control (GPC) as a valid mechanism in Colorado. [read post]
9 Jan 2024, 8:58 am
Due diligence includes reviewing contracts, employment agreements, litigation risks, regulatory compliance, and financial statements. 2. [read post]
9 Jan 2024, 8:05 am
After all, it is the courts that create law on this subject, not regulatory agencies. [read post]
9 Jan 2024, 6:35 am
Regulatory updatesBy our count, four agencies proposed changes to their FOIA regulations in 2023 that have not yet been finalized: Defense Nuclear Facilities Safety Board; Office of Management and Budget; Peace Corps; and the Postal Regulatory Commission.Seven agencies issued final rules amending their FOIA regulations in 2023: Department of Commerce; Department of Defense; Department of State; EPA, Office of the Director of National Intelligence; Office of the Intellectual… [read post]
8 Jan 2024, 9:05 pm
Although the executive order signals some government action on AI, the future of AI regulation in the United States still remains uncertain.The post Examining the New Artificial Intelligence Executive Order first appeared on The Regulatory Review. [read post]
8 Jan 2024, 6:26 pm
Diligence related to FDA-regulated industries often involves not only FDC Act review, but also federal and state False Claims Acts, and Anti-Kickback Statutes, along with other state and local laws and regulations. [read post]
8 Jan 2024, 2:10 pm
Under the Resolution Agreement reached with Optum, Optum agreed to pay $160,000 to OCR as well as implement a corrective action plan that requires workforce training, reporting records requests to OCR, and reviewing and revising as necessary its right of access policies and procedures to provide timely responses to requests. [read post]
8 Jan 2024, 12:34 pm
Once filed, FINRA appoints an arbitrator to review the case, determine if the investor deserves restitution, and if ruled in favor, issue an award for damages. [read post]
