254 changes Guidance, last 7 days
NIST Report on Challenges in Monitoring Deployed AI Systems
The National Institute of Standards and Technology (NIST) has published a report detailing challenges in monitoring deployed artificial intelligence (AI) systems. The report, based on practitioner workshops and literature review, identifies gaps and opportunities for innovation in post-deployment AI monitoring methodologies.
NIH Updates Data Management and Sharing Plan Elements
The National Institutes of Health (NIH) has updated the required elements for Data Management and Sharing Plans (DMS Plans) for research applications. Effective for due dates on or after May 25, 2026, a new, simpler format page will be required. This update aims to streamline the process and reduce applicant burden by clarifying common areas of confusion and removing extraneous details.
OFAC Venezuela-Related General License 51
The Office of Foreign Assets Control (OFAC) has issued Venezuela-related General License 51, authorizing certain activities involving Venezuelan-origin gold. This license provides specific exemptions to sanctions regulations for authorized transactions.
Draft Guidance: Responding to FDA Form 483 Observations for Drug Manufacturers
The FDA has issued draft guidance for drug manufacturers on how to respond to observations noted on FDA Form 483 following CGMP inspections. This guidance is intended to assist domestic and foreign manufacturers in assessing conformity with CGMP requirements.
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