News & Analysis as of

Food and Drug Administration (FDA) Public Policy

Goodwin

Goodwin’s 2025 Rare Disease Symposium: Momentum Builds for Addressing Critical Diagnosis and Treatment Gaps

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Goodwin’s 2025 Rare Disease Symposium, held on February 5 in Boston and virtually, gathered patient advocates and caregivers, providers, researchers, biotech and medtech leaders, investors, and policy experts to discuss the...more

Goodwin

How the Trump Administration Could Reshape Regulation in the Life Sciences Sector

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Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more

Alston & Bird

Look Ahead to the Week of July 22: Congress Returns as 2024 Election Takes Center Stage

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Both the House and Senate are back for two weeks before departing for August recess. Last week, Republicans rallied support for the nomination of former President Donald Trump and his running mate, JD Vance, at the Republican...more

Holland & Knight LLP

Holland & Knight Health Dose: July 9, 2024

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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....more

Alston & Bird

Look Ahead to the Week of March 4: The State of the Union and Government Spending

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Look Ahead to the Week of March 4: The State of the Union and Government Spending - Both the Senate and House are in session. This week, Congress will attempt to pass the first tranche of government spending bills after...more

Holland & Knight LLP

Holland & Knight Health Dose: October 17, 2023

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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. ...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 40

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Outlook for This Week in the Nation’s Capital - Congress. Congress is in recess this week. Shortly after returning from the midterm election break, both parties will hold votes on their leadership. House Speaker Nancy Pelosi...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 39

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Outlook for This Week in the Nation’s Capital - Congress.  Congress is in recess to campaign for the upcoming midterms. Senate Majority Whip Dick Durbin (D-IL) on Wednesday said the Senate will focus on judicial nominations...more

Polsinelli

Fall Congressional Forecast: Eye on Federal Funding and Health Care

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Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 32

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Outlook for This Week in the Nation’s Capital - Congress. The House and Senate are both in recess until Labor Day. Once they return, they will have a packed to-do list ahead of the November elections, which may include...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

Alston & Bird

Food and Drug Amendments of 2022 (PDUFA VII)

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Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 22

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Outlook for This Week in the Nation’s Capital - Congress. The House and Senate are back in session this week. The House plans to vote on numerous Education and Labor, Small Business, and Transportation and Infrastructure...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 20

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Outlook for This Week in the Nation’s Capital - Congress. The House is in a committee work period, and the Senate is in session this week. Senate Majority Leader Chuck Schumer (D-N.Y.) is planning a procedural vote this week...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 18

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Outlook for This Week in the Nation’s Capital - Congress. Both chambers are in session this week. Senate Democrats plan to vote on abortion rights legislation later this week, though the bill is fully expected to fail given...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #3

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Alston & Bird Health Care Week in Review - March 2022 #1

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #3

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Ruder Ware

Emergency Use Authorization Vaccines – A Caution to Employers

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Happy New Year! As we move into 2021, we know that many of you are considering whether to require employees to get the COVID-19 vaccination. The current COVID-19 vaccines have received Emergency Use Authorization (“EUA”)...more

Holland & Knight LLP

Healthcare Policy Update: Election Edition

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A presidential race called by media outlets for former Vice President Joe Biden, coupled with a diminished Democratic majority in the U.S. House of Representatives and a narrowly divided Senate, translates into a federal...more

Rivkin Radler LLP

Wearables Brands Fight for Healthcare Space

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Manufacturers of activity trackers and smartwatches have been fighting over the “serious” healthcare market for several years. Companies such as Apple (previously discussed here), Fitbit (previously discussed here), and...more

Bergeson & Campbell, P.C.

Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology

With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the...more

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