News & Analysis as of August 31, 2025

Cybersecurity › Pharmaceutical Industry › Final Guidance

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on 8/22/2025

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on 5/11/2022

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

A Different Kind of “Virus”: FDA Follows NIST Framework in Cybersecurity Guidance for Medical Devices

Mintz - Privacy & Cybersecurity Viewpoints on 10/9/2014

In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more

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