News & Analysis as of

Medical Devices › Supply Chain › Healthcare

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Skadden, Arps, Slate, Meagher & Flom LLP on

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Troutman Pepper Locke

Is Bayh-Dole the Next Lever in the Push to Onshore Pharma Manufacturing?

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The U.S. government is pushing to redomesticate the manufacturing of pharmaceutical, biotech, gene therapy, and medical device products, both to bolster U.S. manufacturing generally and to address continuing shortages of...more

Bricker Graydon LLP

The Impact of Tariffs on Medical Equipment Manufacturing in Kentucky

Bricker Graydon LLP on

In our recent publication, “The Impact of Tariffs on the Insurance Industry,” we explored how the sweeping tariff policy announced by President Donald Trump is affecting various insurance sectors....more

Rivkin Radler LLP

ADA Joins Coalition Seeking Tariff Exemption for Medical and Dental Supplies

Rivkin Radler LLP on

The American Dental Association (ADA) has joined a coalition of other healthcare organizations in writing a letter to U.S. Trade Representative Jamieson Greer urging the Trump administration to exempt medical and dental...more

Akin Gump Strauss Hauer & Feld LLP

Three Questions with Sedgwick’s Jeremy Schutz

Akin Gump Strauss Hauer & Feld LLP on

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more

McDermott Will & Schulte

Bulletin Concurrence XII - Paris │Avril ● Mai ● Juin ● Juillet ● Aout 2024

McDermott Will & Schulte on

1. CONTENTIEUX - NOUVEAU RISQUE DE REMISE EN CAUSE À POSTERIORI D’OPÉRATIONS NON NOTIFIABLES - Par une décision du 2 mai 2024, l’Autorité de la concurrence (ci-après l’ « Autorité ») a fait pour la première fois...more

Goldberg Segalla

FDA to EPA: Pump the Brakes on New EtO Rules During Supply Chain Shortage

Goldberg Segalla on

With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused...more

Knobbe Martens

FDA Updates Medical Device Shortages List

Knobbe Martens on

The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - January 2022

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Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Arnall Golden Gregory LLP

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

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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

Alston & Bird

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

Alston & Bird on

In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more

McDermott Will & Schulte

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

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Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

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On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

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