News & Analysis as of

Risk Mitigation Draft Guidance

Mintz - Antitrust Viewpoints

NIST Releases Updated Draft Guidance for Federal Agencies’ Use of AI in Identity Verification Systems — AI: The Washington Report

On August 21, the National Institute of Standards and Technology (NIST) released the second draft of its revised Digital Identity Guidance, which NIST first published in 2004 and last revised in 2017. The draft guidance...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Goodwin

Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

Goodwin on

I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more

Carlton Fields

Time to Flush Certain Restrictions on Rebates?

Carlton Fields on

The NAIC and states are reviewing whether to flush those provisions of state anti-rebating laws that inhibit innovation in the insurance industry. The NAIC Unfair Trade Practices Act (#880) prohibits offering any premium...more

Hogan Lovells

FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration...more

King & Spalding

King & Spalding Lawyers Discuss The Regulatory Landscape At Medical Device Cybersecurity Risk Mitigation Conference

King & Spalding on

On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

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