Podcast: President Biden's Use of the Defense Production Act - Diagnosing Health Care
Supporting Health Through Supply Chain Management
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Blakes Continuity Podcast: Life Sciences: Liability and Immunity During COVID-19
K&L Gates Triage: Using Drones in Medicine
On May 19, 2021, the Federal Emergency Management Agency (“FEMA”) announced that it is removing export restrictions on four categories of personal protective equipment (“PPE”) and other items used to address the effects of...more
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
- On August 10, 2020, FEMA extended the duration of its restrictions on the export of certain shipments of PPE through December 31, 2020. - The August 10 notice narrowed the types of PPE covered by the restrictions to...more
On August 6, 2020, the Federal Emergency Management Agency (“FEMA”) issued a temporary final rule modifying the list of Personal Protective Equipment (“PPE”) subject to FEMA’s export restrictions and extending the...more
On 31 March 2020 the China Ministry of Commerce, the National Medical Products Administration (NMPA), and the General Administration of Customs (GAC) issued the Notice on the Orderly Exportation of Medical Supplies...more
Report on Supply Chain Compliance 3, no. 9 (April 30, 2020) - After Chinese medical supplies were criticized for low quality, including masks, tests and gloves sent to Europe, the Chinese government responded with new...more
As the COVID-19 pandemic has expanded exponentially, so too has the demand by hospitals and other healthcare providers for masks and other medical personal protective equipment (PPE) to protect doctors, nurses, and other...more
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
Amidst the global COVID-19 pandemic many things are uncertain. For businesses, this is further compounded by the rapidly changing and temporary measures that governments are launching to limit the financial fallout of the...more
The EU has extended the export restrictions on certain items of Personal Protective Equipment (PPE) for a further period of 30 days. On 24 April, the European Commission (Commission) extended the export controls on PPE...more
On 17 April the Federal Emergency Management Agency (FEMA) released significant exceptions (effective Friday 17 April, but to be published on 21 April) to FEMA's temporary final rule prohibiting exports of certain personal...more
In an Alert published on April 10, we discussed temporary restrictions that the Federal Emergency Management Agency (FEMA) had placed on the export from the United States of certain personal protective equipment (PPE). ...more
- Effective April 17, 2020, FEMA expanded exemptions to its April 7, 2020, Temporary Rule that implemented export restrictions on certain shipments of personal protective equipment. - FEMA issued the Temporary Rule to...more
On April 21, 2020, the US Federal Emergency Management Agency (FEMA) is due to publish a notification of exemptions (Notification) to the restrictions it has recently imposed on the export of five types of personal protective...more
The Federal Emergency Management Agency has left many important questions blowing in the wind as a result of a Notification of Exemptions action published for public inspection on Friday, April 17, 2020. The final action will...more
On April 3, 2020, President Trump issued a Presidential Memorandum directing the Department of Homeland Security, through the Federal Emergency Management Agency (FEMA), to utilize the Defense Production Act to restrict the...more
On April 10, 2020, the U.S. Federal Emergency Management Agency (FEMA) published a Temporary Final Rule as part of its response to the COVID-19 pandemic. The Temporary Final Rule allocates certain scarce or threatened...more
FEMA exercised the authority recently granted to it by Executive Orders and pursuant to the Defense Production Act to regulate and redirect respirators, surgical masks, gloves, and other personal protective equipment (PPE) ...more
On April 9, 2020, US Customs and Border Protection (CBP) issued a Memorandum to its field operators providing guidance on the implementation of the US Federal Emergency Management Agency’s (FEMA) Temporary Final Rule (TFR)...more
On Friday, April 10, 2020, the United States will join the list of countries requiring authorization for exports of certain medical and health-related equipment. Specifically, as of that date, authorization from the U.S....more
- Beginning April 7, 2020, CBP is authorized to temporarily detain all shipments of five categories of personal protective equipment used in the response to and treatment of COVID-19, pursuant to a Temporary Rule issued by...more
On Friday, April 10, Federal Emergency Management Agency (FEMA), is expected to publish a temporary final rule that would restrict the exportation of certain personal protective equipment (PPE) from the United States....more
The Belgian federal agency for medicines and health products (AFMPS or FAGG) provides that Belgium acts as a logistical platform for certain medicinal products....more
The Federal Emergency Management Agency (FEMA) has exercised its delegated authority under the Defense Production Act (DPA) to issue a temporary final rule (Prioritization and Allocation of Certain Scarce or Threatened Health...more