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Regulatory Agenda › New Guidance › Healthcare

McDermott Will & Emery

End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

McDermott Will & Emery on

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

Bass, Berry & Sims PLC on

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

Bass, Berry & Sims PLC

HHS Releases Cybersecurity Performance Goals for Healthcare Organizations

Bass, Berry & Sims PLC on

In response to the number of successful, large-scale ransomware attacks affecting healthcare organizations nearly tripling since 2018, the Department of Health and Human Services (HHS) has released guidance outlining its...more

Proskauer - Health Care Law Brief

HHS Publishes Roadmap of New Strategy for Cybersecurity in the Healthcare Sector

Proskauer - Health Care Law Brief on

The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data...more

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

Hogan Lovells on

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

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