K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to...more
It has been over a year since the beginning of the COVID-19 pandemic and although many restrictions are beginning to lift, one that has not is the eviction moratorium. In August of 2020, (after the CARES Act eviction...more
On May 5, 2021, the U.S. District Court for the District of Columbia struck down the Centers for Disease Control and Prevention's nationwide eviction moratorium. According to the court, the CDC exceeded the scope of its...more
Earlier this year, the Eastern District of Texas invalidated — commerce clause grounds — the Centers for Disease Control and Prevention’s (CDC’s) ability to halt residential evictions during the COVID-19 pandemic....more
The Centers for Disease Control and Prevention’s (CDC’s) federal moratorium for residential evictions, which was set to expire on March 31st, was just extended through the end of June. A recent trend in federal cases may put...more
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more
On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days, beginning on October 23 (the date the...more
On September 1, 2020, the Centers for Disease Control and Prevention (CDC) announced that it was issuing an order (CDC Order) to temporarily halt residential evictions to prevent the further spread of COVID-19. The CDC Order...more
On September 4, 2020, to prevent the further spread of COVID-19, the Centers for Disease Control and Prevention (“CDC”) issued an Order under Section 361 of the Public Health Service Act to temporarily halt residential...more
On Thursday, July 23, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days through October 22. This update...more
Businesses await clarity from the federal government on liability protections for injuries resulting from COVID-19. Current federal law provides liability protection to businesses but is limited to COVID-19 related...more