Reporting Requirements, Supply Chain, Food and Drug Administration (FDA)

FDA Calls for Stronger Industry Collaboration on Infant and Child Food Recalls

Foley & Lardner LLP on 8/13/2025

Call to Action. In a letter dated July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a clear call to action for manufacturers, distributors, and retailers of infant formula, baby food, and children’s food...more

Field Alert Reporting: Supplier Contracting Implications for Drug Developers

Goodwin on 10/21/2021

For emerging companies establishing their first supply chains, ensuring notification requirements in supply agreements for when commercial-stage manufacturing issues arise may not be top of mind. However, it is important for...more

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

Hogan Lovells on 9/11/2020

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

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

Akin Gump Strauss Hauer & Feld LLP on 8/13/2020

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

The “Preventing Essential Medical Device Shortages Act of 2020”: COVID-19 Side Effect that Could Permanently Harm Medical Device...

Spilman Thomas & Battle, PLLC on 4/28/2020

The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the...more

New Federal Contract Reporting Requirements Aimed at Protecting Supply Chains Through Detection of Counterfeit Parts

Seyfarth Shaw LLP on 12/20/2019

Federal contractors already subject to a myriad of reporting requirements should be prepared for yet another. Effective December 23, 2019, a new Federal Acquisition Regulation (“FAR”) provision entitled “Reporting of...more

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Mintz - Health Care Viewpoints on 7/13/2017

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

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