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
Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a Draft List of Recognized...more
Massachusetts AG Andrea Joy Campbell settled with Regional Home Care, Inc., a medical equipment supplier and service provider, to resolve allegations that the company’s billing and debt collection practices violated the...more
The Medicines and Healthcare products Regulatory Agency has extended the EC Decision reliance procedure (EC DRP) to apply until 31 December 2023....more
President Donald Trump signed an Executive Order (EO) on Thursday, August 6, 2020 directing federal agencies to “Buy American” when purchasing “essential” drugs, medical supplies and equipment rather than purchase these...more
- Legislation to bolster the U.S. supply chain for medical equipment becomes an issue of bipartisan focus in Congress. - Differing proposals included in the House and Senate “Phase 4” COVID-relief proposals as well...more
Report on Supply Chain Compliance 3, no. 13 (June 25, 2020): Chinese auto manufacturer BYD Auto Co. Ltd. received approval from the United States National Institute for Occupational Safety and Health (NIOSH) to sell U.S....more
Healthcare providers who received or receive payments from the CARES Act Provider Relief Fund (“PRF”) may only use the payment for permissible purposes, must document and report the proper use, and return any excess funds to...more
In the midst of the Coronavirus (COVID-19) pandemic, states are closely monitoring companies’ pricing of personal protective equipment, food and other essential supplies. This On the Subject offers an overview of state price...more
Even though states are leading the way on price gouging enforcement, recent action in Congress may lead to overlapping federal government enforcement. Recent Congressional letters, statements, and proposed bills show a...more
On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more
As the world faces the unprecedented spread of the COVID-19 virus, essential resources such as hand sanitizer, face masks, medical gowns, and ventilators are suddenly in short supply. In response to the dwindling availability...more
On August 7, 2015, the U.S. Government issued a revised Guidance regarding Iran and also issued a Third Amended Statement of Licensing Policy on Activities Related to the Safety of Iran’s Civil Aviation Industry. The bottom...more