Stephanie Kennan on Food and Drug Administration (FDA)

Washington Healthcare Update - December 2021 #2

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

12/14/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , Popular , Proposed Rules , Vaccinations

Washington Healthcare Update - December 2021 #1

Upcoming Hearings/Markups - December 8 - House Agriculture Committee, Nutrition, Oversight, and Department Operations Subcommittee Hearing: “Review of USDA Nutrition Distribution Programs”...more

12/7/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , HRSA , Infectious Diseases , Medicare , Physician Fee Schedule , Popular , Proposed Rules , Vaccinations

Washington Healthcare Update - November 2021 #4

Congress - House - House Passes Reconciliation Package - On Nov. 19, the House passed the $1.7 trillion reconciliation package with a vote of 220-213. Votes came the morning after the Congressional Budget Office (CBO)...more

11/23/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , Medicare , Pharmaceutical Industry , Physician Fee Schedule , Popular , Prescription Drugs , Proposed Rules

Washington Healthcare Update - November 2021 #3

This week in Washington: CBO Scores Reconciliation Package While House Waits....more

11/16/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Medicare Part B , OIG , Proposed Rules

Washington Healthcare Update - November 2021 #2

This week in Washington: Congressional Democrats reach drug pricing agreement; bipartisan infrastructure bill goes to President Biden’s desk with budget reconciliation bill delayed....more

11/9/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Draft Guidance , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

Washington Healthcare Update - November 2021 #1

Upcoming Hearings/Markups - November 2 - House Veterans’ Affairs Committee, Subcommittee on Technology Modernization Hearing: “Next Steps: Examining Plans for the Continuation of the Department of Veterans Affairs...more

11/2/2021 / Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , Infectious Diseases , Pfizer , Pharmaceutical Industry , Proposed Rules

Washington Healthcare Update - October 2021 #4

Upcoming Hearings/Markups - October 26 - House Education and Labor Committee, Subcommittee on Workforce Protections and the Subcommittee on Civil Rights and Human Services Hearing: “Protecting Lives and Livelihoods:...more

10/26/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Final Rules , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Vaccinations

Washington Healthcare Update - October 2021 #3

This week in Washington: Debt ceiling measure signed by President Biden; default averted for at least a month. Discussions about budget reconciliation continue....more

10/19/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Drug Pricing , Emergency Use Authorization (EUA) , Final Rules , Food and Drug Administration (FDA) , Health Care Providers , Medicare , Prescription Drugs , Proposed Rules

Washington Healthcare Update - October 2021 #2

This week in Washington: Reconciliation delayed; short-term debt ceiling fix passed....more

10/12/2021 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , GAO , Medicare , Pfizer , Pharmaceutical Industry , Proposed Rules

Washington Healthcare Update - October 2021 #1

This week in Washington: Continuing resolution passes House, government shutdown averted for now, infrastructure and reconciliation package votes delayed....more

10/5/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , Proposed Rules

Washington Healthcare Update - September 2021 #3

Upcoming Hearings/Markups - September 27 - House Rules Committee Meeting: to discuss H.R. 3110 — PUMP for Nursing Mothers Act, H.R. 3992 — Protect Older Job Applicants (POJA) Act and H.R. 2119 — Family Violence Prevention...more

9/28/2021 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Final Rules , Food and Drug Administration (FDA) , GAO , OIG , Pfizer , Popular , Proposed Rules , Skilled Nursing Facility , Vaccinations

Washington Healthcare Update - September 2021 #2

This week in Washington: Reconciliation markup passes out of House Energy and Commerce and Ways and Means Committees....more

9/21/2021 / Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Medicaid , Skilled Nursing Facility

Washington Healthcare Update - September 2021

This week in Washington: Reconciliation markups begin. Congress - Upcoming Hearings/Markups - House - • Need for Continuing Resolution to Fund the Government...more

9/14/2021 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , Generic Drugs , Long Term Care Facilities , Medicaid , OIG , Popular , Proposed Rules , Skilled Nursing Facility

Washington Healthcare Update - August 2021 #4

This week in Washington: House passes budget resolution with compromise, setting up a September deadline for infrastructure bill vote....more

8/31/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , Physician Fee Schedule , Proposed Rules , Telehealth , Vaccinations

Washington Healthcare Update - August 2021 #3

This week in Washington: Senate passes infrastructure bill; Senate passes budget resolution with reconciliation instructions; Congress enters recess with House members to return Aug. 23....more

8/17/2021 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicaid , Medicare , Pharmaceutical Industry , Physician Fee Schedule , Popular , Prescription Drugs , Proposed Rules , Skilled Nursing Facility

Washington Healthcare Update - August 2021 #2

This week in Washington: House in recess, Senate continues to debate bipartisan infrastructure bill, Senate to pass a budget resolution with reconciliation instructions before they leave for recess....more

8/10/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , OIG , Physician Fee Schedule , Proposed Rules

Washington Healthcare Update - August 2021

This week in Washington: Senate agrees on infrastructure compromise, budget resolution with reconciliation instructions to be voted on....more

8/3/2021 / Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , OCR , Opioid , Prescription Drugs

Washington Healthcare Update - July 2021 #3

This week in Washington: Infrastructure talks continue, Labor HHS Appropriations bill clears House Committee and is on the way to the floor....more

7/27/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , GAO , Medicare , Proposed Rules , Vaccinations

Washington Healthcare Update - July 2021 #1

This week in Washington: Senate in recess, conversations continue on infrastructure and administration’s health initiatives. ...more

7/7/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Medicaid , Opioid , Popular , Proposed Rules , Substance Abuse

Washington Healthcare Update - June 2021 #4

This week in Washington: Infrastructure deal struck, but it still has a long road ahead to passage; Senate Budget Committee discussed draft resolution with health initiatives included....more

6/29/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Drug Pricing , Food and Drug Administration (FDA) , GAO , Medicare , Prescription Drugs , Vaccinations

Washington Healthcare Update - June 2021 #3

This week in Washington: Supreme Court dismisses challenge to the Affordable Care Act....more

6/22/2021 / Affordable Care Act , Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Popular , Section 340B , Vaccinations

5/18/2021 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , Proposed Rules , Provider Relief Fund , Section 340B

Washington Healthcare Update - May 2021 #2

This week in Washington: Biden Administration expresses support for WTO TRIPS Waiver....more

5/11/2021 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Hospitals , MACPAC , Pharmaceutical Industry , Prescription Drugs , Proposed Rules , Skilled Nursing Facility

Stephanie Kennan

McGuireWoods LLP

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