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Disclosure Requirements Healthcare Food and Drug Administration (FDA)

Holland & Knight LLP

FDA Announces Prompt Disclosure of Complete Response Letters, Release of Additional Letters

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 4, 2025, announced the release of 89 previously unpublished Complete Response Letters (CRLs), building on the previous release of more than 200 CRLs on July 10, 2025. The...more

Orrick, Herrington & Sutcliffe LLP

FDA’s “Radical Transparency” Arrives: Real-Time Publication of CRLs Poses New Exposures for Innovative Pharmaceutical Companies

The U.S. Food and Drug Administration (FDA) has unveiled a sweeping transparency initiative that will fundamentally change how innovative drug and biologic developers interface with the Agency and the market. ...more

Clark Hill PLC

The Learned Concierge - July 2025, Vol. 21

Clark Hill PLC on

The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries. Cybersecurity & Privacy - The Monthly Rundown of All Things Cyber, Privacy,...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

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