Notice 3 Jul 2025 regulatory compliance, technology, fda, ai, drug safety, pharma

💊FDA Seeks Comments on Drug Safety Technology Meeting Program

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Emerging Drug Safety Technology Meeting (EDSTM) Program.

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Notice 28 Feb 2025 collaboration, united states, research, antitrust, membership, ai, international, legal affairs

🤝Notice on AI Infrastructure Alliance Membership Changes and Antitrust

The Department of Justice announces changes to the membership of the AI Infrastructure Alliance, Inc., under the National Cooperative Research and Production Act. Significant amendments, including withdrawals from various companies and organizations, are outlined, highlighting the implications for antitrust liability and ongoing collaborative efforts.

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Compliance, Regulation 15 Jan 2025 compliance, regulation, business risk, ai, nist, dual-use

📜NIST Requests Comments on AI Misuse Risk Management Guidelines

The U.S. Artificial Intelligence Safety Institute (AISI), housed within NIST at the Department of Commerce, requests comments on an updated draft document responsive to Section 4.1(a)(ii) and Section 4.1(a)(ii)(A) of Executive Order 14110 on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI) issued on October 30, 2023 (E.O. 14110). This draft document, NIST AI 800-1, Managing Misuse Risk for Dual-Use Foundation Models, can be found at https:// nvlpubs.nist.gov/nistpubs/ai/NIST.AI.800-1.ipd2.pdf. This document is an update to an initial public draft and includes changes based on the previous round of public comment, as well as two new appendices that apply these guidelines to (1) chemical and biological misuse risk and (2) cyber misuse risk.

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