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Supply Chain Medical Devices Public Health

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

Stikeman Elliott LLP

New Regulatory Amendments Under the Food and Drugs Act: Addressing Drug and Medical Device Shortages in Canada

Stikeman Elliott LLP on

On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...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

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

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Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

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 In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more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

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 22

Jones Day on

This regular update (no. 22 | 22 September 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

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

Polsinelli

COVID-19 Challenges Medical Equipment Supply Chains

Polsinelli on

The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment...more

Hogan Lovells

Belgium follows the FDA's approach on the reprocessing of surgical masks and FFP2/FFP3 facemasks

Hogan Lovells on

Given the challenges in maintaining the supplies of healthcare materials such as surgical masks and FFP2 and FFP3 face masks, the Belgian Task Force on shortages, a working group set up by the Belgian Federal Agency for...more

Seyfarth Shaw LLP

Outlook of China’s Health Care Sector in Light of COVID-19

Seyfarth Shaw LLP on

China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....more

Goodwin

U.S. Cares Act Supply Shortage Provisions: What Drug And Device Manufacturers Need To Know

Goodwin on

On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion...more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

Hogan Lovells on

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

McDermott Will & Schulte

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Polsinelli

What COVID-19 Means for FDA-Regulated Industry

Polsinelli on

U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more

Hogan Lovells

NHS medicine and device suppliers urged to carry out supply chain coronavirus risk assessment

Hogan Lovells on

At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more

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