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Regulatory Requirements Supply Chain Manufacturers

Butler Snow LLP

A New Look at an Old Hot Topic: The Internet of Things

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In 1999, computer scientist Kevin Ashton coined the term “the Internet of Things” (“IoT”) in order to put a name to his idea of using RFID chips to track items as they moved throughout a supply chain. “Though there is no...more

White & Case LLP

The EU’s CBAM Implementing Regulation is ready; are you?

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The EU's Carbon Border Adjustment Mechanism (the "CBAM") reporting obligations started applying from 1 October 2023. The final CBAM Implementing Regulation introduces further insight and key clarifications. The CBAM...more

Quarles & Brady LLP

Drug Supply Chain Security Act Compliance Extended But Trading Partners Should Still Prepare Now

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On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more

Quarles & Brady LLP

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

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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

White & Case LLP

Four things to know when preparing for EU Carbon Border Adjustment Mechanism reporting

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The application of the EU's Carbon Border Adjustment Mechanism ("CBAM") is fast approaching for importers and manufacturers of products in the cement, fertiliser, iron, steel, aluminium, hydrogen and electricity producing...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

American Conference Institute (ACI)

[Event] Legal, Regulatory & Compliance Forum on Dietary Supplements - June 29th - 30th, New York, NY

American Conference Institute in collaboration with the Council for Responsible Nutrition (CRN) are excited to welcome you back to New York for the “return to live” reunion that the dietary supplements industry has been...more

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Hogan Lovells

The TGA and the Iron Mask

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In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more

BCLP

European Chemicals Agency SCIP Database is launched and ready for use

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At the end of October, the European Chemicals Agency (ECHA) launched the SCIP database. When populated, the database will ensure that information on articles in the EU that contain substances of very high concern (SVHCs) is...more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

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On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Society of Corporate Compliance and Ethics...

Chemical Watch releases report on regulatory developments in the electronics industry

Report on Supply Chain Compliance 3, no. 11 (May 28, 2020) - A free report details some of the developments within the electronics industry during the COVID-19 pandemic. According to the report...more

Hogan Lovells

Business integrity for consumer companies

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Consumer companies around the world are incorporating sustainability, business integrity, and brand purpose into their business operations. This can include procuring ethically sourced products, ensuring fair pay, or...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

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In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Seyfarth Shaw LLP

President Trump to Restore Tariffs on Aluminum and Steel Imports from Brazil and Argentina

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While China commands the media spotlight in the global war on trade, new trade battles are being waged south of the equator. On Monday December 2, 2019, President Trump announced that he would reinstate tariffs on aluminum...more

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more

Orrick, Herrington & Sutcliffe LLP

California Sets the Standard With a New IoT Law

This past September Governor Brown signed into law Senate Bill 327, which is the first state law designed to regulate the security features of Internet of Things (IoT) devices. ...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

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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

Hogan Lovells

Legislative and Regulatory Update on Federal Supply Chain Risk Management

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The U.S. Government is renewing its focus on mitigating technological risks by regulating the supply chain for various goods and services. ...more

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