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Proposed Rules Coronavirus/COVID-19 Food and Drug Administration (FDA)

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

Mintz - Health Care Viewpoints

The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule

The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule...more

McGuireWoods Consulting

Washington Healthcare Update - September 2023 #3

This Week in Washington: House appropriations talks continue, Senate vote to advance mini omnibus fails; Lower Costs, More Transparency Act pulled from House consideration; House Budget Committee marks up budget resolution...more

McGuireWoods Consulting

Washington Healthcare Update - September 2023 #2

This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to...more

Jones Day

Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Jones Day on

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

McGuireWoods Consulting

Washington Healthcare Update - May 2023 #2

This Week in Washington: Debt Ceiling Continues to Loom Over the Capitol; DEA Extends COVID-19 Controlled Medications Prescribing Telehealth Flexibilities...more

Foley & Lardner LLP

Foley & Lardner Comment Letter on DEA Telemedicine Controlled Substance Proposed Rule

Foley & Lardner LLP on

On March 1, 2023, the Drug Enforcement Agency (DEA) officially published proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The DEA gave the public a 30...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

Mintz - Health Care Viewpoints

Regulatory Roundup: Important FDA Developments at the End of September 2022

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more

McGuireWoods Consulting

Washington Healthcare Update - August 2022 #3

This Week in Washington: Administration focuses on mental health and monkeypox issues...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 - August 2022

This Week in Washington: The Senate waits to see if budget reconciliation agreement has enough votes to pass....more

McGuireWoods Consulting

Washington Healthcare Update - July 2022 #2

This Week in Washington: Sen. Manchin Expresses Support for a More Limited Budget Reconciliation Package That Includes Health Provisions...more

McGuireWoods Consulting

Washington Healthcare Update - July 2022

This Week in Washington: CMS Releases the Physician Fee Schedule Proposed Rule...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

Foley & Lardner LLP on

As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...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 #2

This Week in Washington: Senate Fails to Advance Bill Protecting Abortion Rights After Supreme Court Draft Opinion Leak...more

Foley & Lardner LLP

USPTO Proposes To Require Electronic PTE Applications

Foley & Lardner LLP on

The USPTO has issued proposed rules to make permanent a Covid-19-related change in the manner in which applications for patent term extension under 35 USC § 156 are to be filed. While the Covid-19-related changes permitted...more

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