News & Analysis as of

Personal Protective Equipment Pharmaceutical Industry

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments for June 2025

Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more

Gibney Anthony & Flaherty, LLP

Counterfeit Covid-19 Vaccines: Impacting Public Health and Safety

The other shoe has dropped! At least it has in the world of counterfeit pharmaceuticals. Since early in the pandemic, the US has faced a significant and still ongoing wave of counterfeit PPE entering the country from abroad....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

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

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

Flaster Greenberg PC

Marcellus Shale Update: 2020: The Year Of The Great Energy Disconnect

Flaster Greenberg PC on

2020 obviously will be the Year of the Pandemic. However, when it comes to energy, 2020 will also be known as the Year of the Great Disconnect. Thanks to the COVID-19 Pandemic, never have fossil fuels been more important...more

Wilson Sonsini Goodrich & Rosati

FDA Declines to Review Certain EUAs, Raising Reimbursement and Liability Issues

The Food and Drug Administration (FDA or the Agency) announced on October 7 that it will no longer review Emergency Use Authorizations (EUAs) for laboratory developed tests (LDTs). LDTs are a distinct category of in vitro...more

Akin Gump Strauss Hauer & Feld LLP

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

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

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. ...more

Hogan Lovells

FDA takes action to reduce surgical mask shortage

Hogan Lovells on

To address the increased usage and shortages of surgical masks as a result of combatting COVID-19, on August 5, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for disposable,...more

Robins Kaplan LLP

Financial Daily Dose 7.10.2020 | Top Story: Gilead Reports Strong Remdesivir Results

Robins Kaplan LLP on

Gilead Sciences Inc. reports that its remdesivir virus treatment has been positively correlated with a 62% reduction in death risks compared with the standard of care in an initial analysis....more

Polsinelli

COVID-19 Update – Prioritized Examination Program for Certain Trademark Applications at the United States Patent and Trademark...

Polsinelli on

Recently the United States Patent and Trademark Office (USPTO) announced a new prioritized examination program for trademark and service mark applications meeting certain requirements. The program allows applicants to...more

Seyfarth Shaw LLP

Chinese Manufacturers of Personal Protective Equipment Gave False U.S. Agent Information to Food and Drug Administration

Seyfarth Shaw LLP on

U.S. health care providers should closely inspect PPE equipment bought from Chinese companies in light of recent revelations regarding the registration practices of approximately 1,300 Chinese entities....more

Blake, Cassels & Graydon LLP

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

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

Hogan Lovells

PREP Act declaration amended to clarify coverage of certain products not directly used for COVID-19

Hogan Lovells on

On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical...more

Hogan Lovells

FDA revises EUA guidance for mask & respirator decontamination and bioburden reduction systems

Hogan Lovells on

On May 26, 2020, the U.S. Food and Drug Administration (“FDA” or “Agency”) issued an immediately in effect guidance, Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – June 2020 #7

Hogan Lovells on

In Washington: White House press secretary Kayleigh McEnany on Monday said that President Trump is “open” to another coronavirus stimulus package and that he still wants a payroll tax cut, which many Republicans do not...more

Hogan Lovells

The AFMPS issues third version of the Alternative Test Protocol for surgical face masks

Hogan Lovells on

On 3 June 2020, the AFMPS issued the third version of the Agency’s alternative test protocol (ATP) for surgical face masks. The alternative test protocol was initially published on 14 April 2020, and allowed masks that had...more

Hogan Lovells

European Commission issues guidance on lawful placing on the market of PPE and medical devices

Hogan Lovells on

On 18 May 2020, the European Commission issued a guidance document, regarding the verification of the lawful placing on the EU market of medical devices and personal protective equipment (PPE) in the COVID-19 context. ...more

White & Case LLP

Increasing Scrutiny of Foreign Investments in the German Healthcare Sector

White & Case LLP on

The COVID-19 pandemic has changed most governments' views on the strategic relevance of the domestic healthcare sectors across the globe. Although the European Commission, and also the German government, have re-emphasized...more

Patrick Malone & Associates P.C. | DC Injury...

With U.S. virus response, taxpayers may need to keep demanding: Who benefits?

Cui bono? That query in Latin — Who benefits? — affirms for linguists that sketchy practices date to Ancient Rome and earlier. But who knew the phrase would be so applicable for U.S. taxpayers considering dubious aspects of...more

Hogan Lovells

Combating COVID-19: Government powers for safeguarding supply of critical products and potential conversion of production – Italy,...

Hogan Lovells on

The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more

BakerHostetler

FDA and State Boards of Pharmacy React to COVID-19 – May 11, 2020 Update

BakerHostetler on

Efforts to increase testing are occurring at the national and state levels. The Food and Drug Administration (FDA) continues to crack down on firms marketing products – including drugs, testing kits and personal protective...more

Hogan Lovells

Pharmaceutical and health care sector : impact of the measures taken in France in the context of COVID-19

Hogan Lovells on

Faced with the unprecedented sanitary crisis caused by the COVID-19 epidemic, Article 4 of emergency law n° 2020-290 of 23 March 2020 has created the new legal concept of a health state of emergency and has invoked this...more

Shook, Hardy & Bacon L.L.P.

COVID-19 Client Primer | UK Medical Device Product Liability

ANALYSIS - Product Liability Risks for Medical Devices in the UK - In order to fast-track the development, manufacture and supply of key medical equipment and devices vital in the fight against COVID-19, governments,...more

66 Results
 / 
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide