K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more
The US Department of Health and Human Services’ (HHS) declaration that COVID-19 remains a public health emergency (PHE) will continue through July 15, 2022, and is expected to be renewed again through October 13, 2022....more
On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to...more
The United States Supreme Court nullified a nationwide residential eviction moratorium that has been in place for nearly a year. Alabama Association of Realtors v. U.S. Department of Health and Human Services, 594 U.S. ----...more
Early in the pandemic, there was a patchwork of federal, state, and local eviction moratoriums, so not all rental housing was covered by a moratorium. On September 4, 2020, the CDC issued an order declaring a national...more
On August 26th, the Supreme Court ended the nationwide eviction moratorium that began in September, 2020, and was set to expire on October 3, 2021. In an unsigned majority opinion, the Court ruled that the CDC exceeded its...more
Eviction moratoria at both the state and federal levels are appearing increasingly vulnerable. On August 12, the U.S. Supreme Court partially enjoined New York’s eviction moratorium, concluding that the state’s...more
On June 29, 2021, the Supreme Court refused to end the nationwide eviction moratorium issued by the Centers for Disease Control and Prevention (CDC), leading to quite a bit of confusion among the Courts of Appeal. In Alabama...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
The nationwide eviction ban imposed by the Centers for Disease Control and Prevention (the “CDC”) was vacated following a sweeping ruling issued by the United States District Court for the District of Columbia earlier this...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
On May 5, 2021, Federal District Judge Dabney Friedrich vacated the Center for Disease Control and Prevention (CDC) nationwide moratorium on residential evictions (the “Order”), which the CDC had recently extended beyond its...more
There has been much discussion about FDA’s recently-issued guidance regarding the development and review of abbreviated new drug applications (“ANDAs”) during the COVID-19 pandemic. The guidance, “Development of Abbreviated...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
In a recent letter to state governors, Acting Secretary of Health and Human Services Norris Cochran signaled the US Department of Health and Human Services’ (HHS’s) commitment to “predictability and stability” in the ongoing...more
On January 7, 2021, Secretary Azar of the U.S. Department of Health and Human Services extended the existing public health emergency for 90 days, until April 21, 2021. Without this extension, the declaration would have...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
The Centers for Disease Control (CDC) recently issued a sweeping moratorium on most evictions through the end of 2020 as a means to stop the spread of COVID-19, which will go into effect on September 4, 2020. According to...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
In light of the public health emergency, the Secretary of Health and Human Services has issued a Notice of Declaration providing immunity from legal liability for activities relating to combatting the new coronavirus. Under...more