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Infrastructure Food and Drug Administration (FDA)

King & Spalding

OIG Increases Expectations for Compliance Officers in Its New Compliance Program Guidance – What Compliance Officers at...

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On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 1, January 2023

Big Boosts to Cybersecurity and Tech Funding in $1.7T Omnibus Bill Signed by Biden - “The bipartisan fiscal 2023 omnibus spending agreement includes $2.9 billion for the Cybersecurity and Infrastructure Security Agency, a...more

Foley & Lardner LLP

What’s Next in Washington? - January 2023 Edition

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The dust from the 2022 Midterm Elections has settled and the 118th Congress has begun. Republicans were successfully able to flip control of the House and now have a 222-212 majority with one vacancy to be filled. Democratic...more

King & Spalding

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

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On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer Software Assurance for...more

Ankura

What's in the Inflation Reduction Act?

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On Tuesday, President Biden signed the Inflation Reduction Act of 2022 after it passed two party-line votes in the House (Final Vote: 220-207) and the Senate (Final Vote: 51-50) where Vice President Kamala Harris cast the...more

Foley & Lardner LLP

What’s Next in Washington? - July Edition

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With just a few short weeks left until August recess, there is no shortage of items on the congressional to-do list. The latest round of Supreme Court decisions has inspired new action within Congress to pass legislation...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 25

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Outlook for This Week in the Nation’s Capital - Congress. The House is in a committee work period this week, and the Senate is in recess....more

Foley & Lardner LLP

Cannabis Mid-Year Update 2022

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Well into the third year of the global pandemic, with record inflation and the uncertain outcomes of geopolitical issues roiling global markets, the cannabis industry has nevertheless continued upon a similar path as recent...more

BakerHostetler

The Weekly Hill Update - June 2022

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Below is this week’s congressional update by BakerHostetler’s Federal Policy team. We’ll continue to post in weeks when both chambers of Congress are in session....more

Brownstein Hyatt Farber Schreck

Health Care Funding Priorities in President Biden’s FY 2023 Budget

Today, Monday, March 28, President Joe Biden unveiled his Fiscal Year (FY) 2023 budget request, the second of his presidency. The $5.7 trillion proposal calls for $1.7 trillion in discretionary spending and $3.7 trillion in...more

Foley & Lardner LLP

What’s Next in Washington? – February

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Despite February being a short month, various proposals are still on the table. As Congress returns from recess this week, it faces a daunting to-do list. Government funding runs out by mid-February, Democrats are looking for...more

BCLP

PFAS Update: A Retrospective on Federal PFAS Regulation in 2021

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As anticipated, 2021 was an eventful year for the regulation of per- and polyfluoroalkyl substances (“PFAS”) at the federal level. BCLP has highlighted the key developments in this document, but this is not intended to be a...more

Sheppard Mullin Richter & Hampton LLP

FDA Proposes Risk-Based and Remote Inspection Strategies in New Report

On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Preventing the Next Pandemic

A recent study of one of the two mRNA-based vaccines revealed positive news on how long the vaccine will effectively prevent against COVID-19 infection. The pandemic has also revealed societal weaknesses that, if addressed,...more

Hogan Lovells

Buy American EO applies domestic preferences for "essential medicines" and "medical countermeasures"

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On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – May 2020 #19

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In Washington - The House will meet for a pro forma session on Monday and the full House is out of session next week. The Senate will reconvene on Monday and resume consideration of John Badalamenti to be United States...more

Morgan Lewis - Well Done

Recipe for Reopening Restaurants and Retail Food Establishments

As restaurants and other retail food establishments begin to reopen around the country, trade associations and the US Food and Drug Administration (FDA) have both issued guidance for retail food establishments that provide...more

Hogan Lovells

COVID-19 Update: FDA and USDA Update COVID-19 Food Safety Guidance Regarding Masks, Inspector Availability, and More

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The U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) recently updated their respective COVID-19 questions and answers guidance. FDA updated its food safety questions and answers guidance on...more

Mintz - ML Strategies

What You Need to Know: State and Federal Updates Related to COVID-19

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...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more

Hogan Lovells

SweynTooth cybersecurity vulnerabilities: considerations for medical device manufacturers

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The U.S. Food and Drug Administration (FDA) announced a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited – may introduce risks for certain Bluetooth enabled medical devices.  ...more

Clark Hill PLC

Window On Washington - Vol. 2, Issue 29

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Outlook for This Week in the Nation's Capital - Minibus on Senate Floor. The Senate is expected to take up a four-bill spending package next week. ...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

Clark Hill PLC

Window on Washington - Vol. 1, Issue 39

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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

Clark Hill PLC

Window On Washington - This Week in the Nation's Capital - Vol. 1, Issue 33

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Continuing Resolution for an Additional Month or Two Becoming More Likely: Key appropriators say lawmakers have discussed a continuing resolution that runs until early February despite previous reports that Congress expected...more

Clark Hill PLC

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 24

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Hurricane Harvey Could be the Most Expensive Natural Disaster in US History: Republican House members from Texas and Louisiana are pressing congressional leaders and top Trump administration officials for immediate federal...more

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