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
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
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
In Washington: On Friday, the House passed a $3 trillion coronavirus relief bill, “The HEROES Act” (H. R. 6800) with a vote of 208-199. The legislation included aid for local governments and additional direct payments...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
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
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
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
It’s now the 24th day of the partial government shutdown and we have yet to see signs of a breakthrough. There doesn’t seem to be much of any negotiating happening at the moment either. Will this be the week where stories of...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
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 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