News & Analysis as of

Regulatory Requirements New Guidance Supply Chain

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

ArentFox Schiff on

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

McCarter & English Blog: Government Contracts...

The “Prestige”: DoD Unveils NIST SP 800-171 Revision 3, Organizationally Defined Parameters

On April 15, 2025, the Department of Defense (DoD) released official guidance on Organizationally Defined Parameters (ODPs) appearing in the newly published NIST SP 800-171 Revision 3. At the same time, the DoD reaffirmed...more

Hogan Lovells

Staying antitrust compliant: New BAFA guidance on sector initiatives in supply chain due diligence

Hogan Lovells on

Supply chain due diligence has firmly taken root in the global regulatory landscape, setting clear compliance expectations on how companies should identify, assess, and address human rights and environmental risks across...more

Latham & Watkins LLP

European Commission Announces Simplifications to the Implementation of the EU Deforestation Regulation

Latham & Watkins LLP on

The updated guidance includes simplification measures allowing due diligence statements’ reuse, annual submission, and management by authorised representatives on behalf of companies....more

IR Global

BIS Updates Freight Forwarder Guidance And Best Practices

IR Global on

The Bureau of Industry and Security (BIS) has recently published a guidance document on its new website aimed at helping freight forwarders and exporters uphold compliance with U.S. export controls and regulatory...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Stinson - Corporate & Securities Law Blog

SEC Releases Sample Letter to Companies Regarding Disclosures Pertaining to Russia’s Invasion of Ukraine and Related Supply Chain...

The SEC has released an illustrative letter that contains sample comments that the Division of Corporation Finance may issue to companies based on their specific facts and circumstances related to Russia’s invasion of Ukraine...more

NAVEX

[Virtual Conference] NAVEX Next: Beyond the Moment - October 22nd, 8:00 am - 2:00 pm PDT

NAVEX on

Register for NAVEX Next, our annual risk and compliance virtual conference. Formerly the Ethics & Compliance Virtual Conference (ECVC), the new name recognizes that we must be forward-looking as we face an increasingly...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

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