News & Analysis as of

Vaccinations Proposed Rules Food and Drug Administration (FDA)

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

McGuireWoods Consulting

Washington Healthcare Update - March 2024

This Week in Washington: Congress averts government shutdown; President issues executive order concerning foreign exploitation of health data; Sen. McConnell announces he is stepping down as leader at the end of the term;...more

McGuireWoods Consulting

Washington Healthcare Update - December 2023 #3

McGuireWoods Consulting on

This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final...more

ArentFox Schiff

Kitchen Sink MDRP Proposed Rule Radically Changes Best Price Determination Resulting in Financial and Operational Challenges for...

ArentFox Schiff on

On May 26, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule titled: “Medicaid Program: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug...more

McGuireWoods Consulting

Washington Healthcare Update - March 2023

This Week in Washington: Workforce issues studied, PBMs under more scrutiny...more

McGuireWoods Consulting

Washington Healthcare Update - February 2023 #2

This Week in Washington: President Biden delivers State of the Union Address, House votes to end CDC COVID-19 Foreign Air Traveler Vaccine Mandate...more

McGuireWoods Consulting

Washington Healthcare Update - February 2023

This Week in Washington: President Biden announces ending date of COVID-19 PHE, House begins investigations into COVID-19 origins; State of the Union scheduled for Feb. 7...more

McGuireWoods Consulting

Washington Healthcare Update - January 2023 #4

This Week in Washington: Fighting over how to proceed on the debt limit; Congress still finalizing committee assignments...more

McGuireWoods Consulting

Washington Healthcare Update - October 2022 #3

McGuireWoods Consulting on

This Week in Washington: Countdown to Election Day- Focus on polls, campaigns and who will be in control of the House and Senate...more

McGuireWoods Consulting

Washington Healthcare Update - August 2022 #2

This Week in Washington: House Passes Inflation Reduction Act by a vote of 220-207...more

McGuireWoods Consulting

Washington Healthcare Update - June 2022 #3

This Week in Washington: Supreme Court Overturns Roe v. Wade and Rules in Becerra v. Empire Health Foundation...more

McGuireWoods Consulting

Washington Healthcare Update - June 2022 #2

This Week in Washington: Supreme Court Rules in Favor of 340B Hospitals, FDA Approves COVID-19 Vaccines for Children Under Five...more

McGuireWoods Consulting

Washington Healthcare Update - June 2022

This Week in Washington: House Passes FDA User Fee Reauthorization Package...more

McGuireWoods Consulting

Washington Healthcare Update - May 2022 #3

This Week in Washington: President Biden Invokes Defense Production Act to Increase Supply of Infant Formula...more

McGuireWoods Consulting

Washington Healthcare Update - May 2022

This Week in Washington: CMS announces the 2023 Notice of Benefit and Payment Parameters Final Rule...more

McGuireWoods Consulting

Washington Healthcare Update - March 2022 #4

This Week in Washington: Senate Questions Supreme Court Justice Nominee Ketanji Brown Jackson...more

McGuireWoods Consulting

Washington Healthcare Update - March 2022

This Week in Washington: President Biden Reiterates Healthcare Priorities and Announces Initiatives in his State of the Union Address...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022 #4

This Week in Washington: President Biden Selects Judge Ketanji Brown Jackson to Nominate to the Supreme Court...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022 #3

Congress - The House is in a district work period this week. The Senate is in a state work period this week. Senate - Short-Term Continuing Resolution Passes Senate and is Signed by the President - On Feb. 18,...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022 #2

This Week in Washington: Continuing Resolution Moves Forward and Senate Sets Up Vote on FDA Commissioner Nomination this Week...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022

Upcoming Hearings/Markups - February 8 - Senate Health, Education, Labor and Pensions Committee Hearing: “Lessons Learned from COVID-19: Highlighting Innovations, Maximizing Inclusive Practices and Overcoming Barriers to...more

McGuireWoods Consulting

Washington Healthcare Update - January 2022 #3

This Week in Washington: President Biden and Speaker Pelosi Open to Moving Pieces of the Build Back Better Act....more

Alston & Bird

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

Alston & Bird on

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

McGuireWoods Consulting

Washington Healthcare Update - January 2022 #2

This week in Washington: Supreme Court Rules on Biden Administration Vaccine Mandates....more

McGuireWoods Consulting

Washington Healthcare Update - December 2021 #2

McGuireWoods Consulting on

This week in Washington: Congress makes agreement on pathway forward to raise the debt ceiling....more

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