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Public Health › Supply Chain › Regulatory Requirements

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

BakerHostetler on

Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

Hogan Lovells

Medicines shortages under the EU pharma law package

Hogan Lovells on

The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more

Jones Day

Chemical Recycling Still Faces Regulatory Challenges in the EU

Jones Day on

Chemical recycling of plastic is at a turning point in Europe, with several large projects poised to start but still facing regulatory and market challenges. As highlighted in the study recently published by consultants...more

Hogan Lovells

The European Commission tackles shortages of critical medicines through the Critical Medicines Act

Hogan Lovells on

On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

Akin Gump Strauss Hauer & Feld LLP on

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

McDermott Will & Schulte on

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

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Arnall Golden Gregory LLP on

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 In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more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

Hogan Lovells on

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

Blake, Cassels & Graydon LLP

Blakes Continuity Podcast: Entering the COVID-19 Marketplace: Proceed with Care

Blake, Cassels & Graydon LLP on

COVID-19 is transforming the way businesses create products and go-to-market, especially when launching health products during a pandemic, on an expedited timeline. How are they managing the regulatory requirements and public...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l March 2020

Shook, Hardy & Bacon L.L.P. on

FDA Warning Letters Provide Opportunity for Food-Safety Reminders During Viral and Bacterial Outbreaks - The U.S. Food and Drug Administration (FDA) sent warning letters to Jimmy John’s Franchise, LLC and its supplier...more

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