Podcast: Private Fund Regulatory Update: Post-U.S. Government Shutdown
III-39 - 2nd Anniversary Special Episode
Podcast: Keeping Up with Recent Changes and Trends in Private Fund Regulation
In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a...more
As of Friday September 29, 2023, the United States Congress has yet to reach a spending agreement, as a result companies with international trade operations should prepare for a potential Federal government shutdown. The...more
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event of a shutdown, 19% of FDA employees would be...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include... ...more
While Congress has a two-week recess in April, there are many priority items on the agenda this month. Less than two weeks after signing the Fiscal Year (FY) 2022 spending package, President Biden released his budget for FY...more
In Washington: POLITICO reporter Burgess Everett tweeted that Senate Majority Leader Mitch McConnell (R-KY) says “negotiators should drop both state and local aid and liability shield provisions in order to reach consensus...more
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: shutdown risk increases as talks stall; Gottlieb’s Hill testimony postponed; more bills...more
The federal government shutdown ended Friday, Jan. 25, 2019, with the enactment of a Continuing Resolution to fund government agencies at approximately FY19 levels through Feb. 15. That means federal employees are headed back...more
Note - On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more
Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more
LEGISLATION, REGULATIONS & STANDARDS - Some FDA Inspectors Called to Work During Shutdown - In a series of tweets, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that about 200 food...more
Highlights this week: Gottlieb warns FDA’s funds running low as shutdown continues; House Dems launch sweeping probe on drug prices, Senate approves Medicaid measures, and more....more
LEGISLATION, REGULATIONS & STANDARDS - USDA Releases GMO Labeling Standard - The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service has released the final National Bioengineered Food Disclosure...more
As the government shutdown continues, administrative agencies have been updating the public on their operating status. The FDA has released a statement on its website explaining that its operations will “continue to the...more
During Shutdown, Commissioner Gottlieb Tries to Reassure Consumers – As the partial shutdown continues, Commissioner Scott Gottlieb tries to reassure the industry and consumers that the FDA will continue to execute its...more
Highlights this week: Nearly 7,000 FDA employees are furloughed amid the ongoing government shutdown; lawmakers introduce a slew of anti-pharma bills; 18 new Democrats land plum spots on key healthcare committees; and more....more
As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the...more
On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day. If the shutdown continues through the weekend, it will be the longest federal government shutdown in U.S....more
The new 116th Congress convened on Thursday, January 3, 2019 as the partial government shutdown, carrying over from the prior Congress, continued into the new year and has now outlasted previous shutdowns. Although the...more
On December 22, 2018, funding expired for certain agencies within the federal government, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS),...more
While many today returned to work after the Holiday season, things remained quieter than usual here in the nation’s capital – with many federal workers furloughed until further notice as the federal government continues to be...more
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
Highlights this week include a lame duck update on year-end health bills and tax provisions; lawmakers reacting to a federal judge ruling the Affordable Care Act is unconstitutional; Sen. Hatch seeks to update Hatch-Waxman;...more
With the government shutdown entering its third day, the Senate scheduled a procedural vote at noon today that could pave the way to end the stalemate – but it’s not clear there’s enough support to break the logjam and reopen...more
Tax Vote This Week: After Senators Corker and Rubio announced their support of the tax bill on Friday afternoon, both Chambers announced their plans to move forward with voting on the compromise tax package this week. The...more