News & Analysis as of

Personal Protective Equipment Medical Devices

White & Case LLP

Biden Administration Expands Section 301 Tariffs on Imports from China, Targeting Green Energy, Metals, Minerals, Port Cranes,...

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On May 14, 2024, the Biden administration announced expansions to the United States’ Section 301 tariffs on imports from China, proposing to raise tariffs on solar panels, electric vehicles, batteries, green energy supply...more

Wiley Rein LLP

The End of an Era: FDA Announces Disposition Plans for COVID-19 Related Guidance Documents

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The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of critical drugs, medical devices, and biologic...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies...

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies...more

Dickinson Wright

Wait, Wait…Don’t Sell Me! FDA and Other Pre-Market Considerations for Commercial Products

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The Food and Drug Administration (FDA) is a consumer protection agency that ensures the safety and efficacy of certain products in the US, such as medical devices, drugs, and prescriptions, tobacco products, cosmetics, food,...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 49

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LATEST KEY DEVELOPMENTS Competition & State Aid • EU General Court annuls COVID-19-related State aid decisions for inadequate reasoning • European Commission receives Recovery and Resilience Plans from 23 Member...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 45

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LATEST KEY DEVELOPMENTS Competition & State Aid • Portugal is first Member State to officially deliver Recovery and Resilience Plan to European Commission • EU Single Resolution Board responds to European...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 40

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LATEST KEY DEVELOPMENTS Competition & State Aid • Launch of Multilateral Working Group of leading competition authorities to assess the effects of mergers in the pharmaceutical sector, including drug pricing •...more

Arnall Golden Gregory LLP

Not Worth the Paper It’s Printed On: FDA Calls Companies to Stop Issuing Misleading Medical Device Establishment Registration...

At the beginning of the COVID-19 pandemic, we saw what seemed to be a surplus of “FDA Registration Certificates” being presented by Chinese manufacturers of face masks and other personal protective equipment (PPE) as evidence...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

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 39

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LATEST KEY DEVELOPMENTS Competition & State Aid • European Commission pursues Fit for Future Platform to simplify EU law, including in the area of State aid, particularly in response to the pandemic • EU approves new...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – March 2021 #3

Alston & Bird on

In the past week, President Biden signed the American Rescue Plan, which provides $10 billion to expand domestic production of medical supplies. The President also announced that all adults in the U.S. will be eligible for...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

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The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

King & Spalding

Group of Nearly 60 WTO Members Seek Unprecedented Waiver from WTO Intellectual Property Protection for COVID-related Medical...

King & Spalding on

Companies holding intellectual property in medical products used in the fight against COVID-19 should be aware of formal efforts by a group of nearly 60 developing countries, led by India and South Africa, to obtain a waiver...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 37

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LATEST KEY DEVELOPMENTS - Competition & State Aid • European Commission launches public consultation on revision of IPCEI Communication • EU approves new and amended Member State measures to support the economy ...more

Jackson Lewis P.C.

Indiana Enacts COVID-19 Liability Shield For Hoosier Businesses

Jackson Lewis P.C. on

In an effort to stimulate safe reopening of the economy and protect companies acting in good faith, Indiana has enacted a COVID-19 immunity shield. Governor Eric Holcomb signed Indiana Senate Bill 1, “Immunity Related to...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 36

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This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS -...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 35

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Competition & State Aid • EU approves new and amended Member State measures to support the economy Trade / Export Controls • EU and India launch the High-Level Dialogue on Trade and Investment, with a particular...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 32

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LATEST KEY DEVELOPMENTS - Competition & State Aid • European Commission launches public consultation on fair taxation in the digital economy • European Commission proposes to further prolong and adjust State aid...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 33

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LATEST KEY DEVELOPMENTS Competition & State Aid • EU approves new and amended Member State measures to support the economy Trade / Export Controls • European Commission announces export transparency mechanism...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 31

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LATEST KEY DEVELOPMENTS - Competition & State Aid • €25 billion Pan-European Guarantee Fund deployed for the first time • EU approves new and amended Member State measures to support the economy Trade / Export...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 30

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LATEST KEY DEVELOPMENTS - Competition & State Aid • European Commission addresses State aid support in Communication on tackling nonperforming loans in the aftermath of COVID-19 pandemic • European Commission...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 29

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This regular update (no. 29 | 15 December 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 28

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LATEST KEY DEVELOPMENTS - Competition & State Aid • EU approves new and amended Member State measures to support the economy • Executive Vice-President and Competition Commissioner Vestager speech on the future of State...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 27

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LATEST KEY DEVELOPMENTS - Competition & State Aid • EU approves new and amended Member State measures to support the economy • European Commission Executive Vice-President Margrethe Vestager speech on COVID-19 State...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 26

Jones Day on

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS...more

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