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Risk Assessment Final Guidance

Smart & Biggar

Health Canada publishes guidance on submitting risk management plans

Smart & Biggar on

As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Federal Regulators Unveil Revised Final Guidance for Healthcare Cybersecurity and HIPAA Compliance

On February 14, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a new, final version of their guidance for...more

Goodwin

FDA’s Final Q&A Guidance on Risk-Based Monitoring of Clinical Trials Provides Additional Recommendations for Sponsors

Goodwin on

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s March 2019 draft...more

Davis Wright Tremaine LLP

White House Finalizes AI Regulatory Framework and Directs Agencies to Develop Plans for AI Regulation and "Non-Regulation"

Overview - The White House, through its Office of Management and Budget (OMB), has issued final Guidance for Regulation of Artificial Intelligence Applications (Guidance) which establishes a framework for federal agencies to...more

Sheppard Mullin Richter & Hampton LLP

ALERT: NIST Issues Final Guidance on Federal Contractor Cybersecurity Standards for Controlled Unclassified Information

On June 19, 2015, the National Institute of Standards and Technology (NIST) published the final version of guidance for federal agencies to ensure sensitive information remains confidential when stored outside of federal...more

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