News & Analysis as of

Food and Drug Administration (FDA) Government Shutdown Pharmaceutical Industry

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Second Quarter of 2025 and Beyond

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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

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

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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

Epstein Becker & Green

Full Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown

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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

BakerHostetler

Capitol Hill Healthcare Update

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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

Hogan Lovells

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

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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

BakerHostetler

Capitol Hill Healthcare Update

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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

Goodwin

Agency Activity During Government Shutdown

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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

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - January 2019 #1

BakerHostetler on

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

BakerHostetler

Capitol Hill Healthcare Update

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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

Patterson Belknap Webb & Tyler LLP

The 2019 U.S. Federal Government Shutdown and its Potential Impact on Biologics

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

Hogan Lovells

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

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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

BakerHostetler

Capitol Hill Healthcare Update

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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

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