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Coronavirus/COVID-19 › Regulatory Agenda › Pharmaceutical Industry

Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms... more +
Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -
McDonnell Boehnen Hulbert & Berghoff LLP

Five Years Ago Today . . .

McDonnell Boehnen Hulbert & Berghoff LLP on

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear."  At...more

Rivkin Radler LLP

DEA Announces New Telemedicine Rules Expanding Access to Controlled Substances

Rivkin Radler LLP on

On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted...more

Foley Hoag LLP

FDA Releases First New COVID-19 Vaccine BLA Guidance Since 2020

Foley Hoag LLP on

Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2023 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more

McDermott+

McDermottPlus Check-Up: May 19, 2023

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The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

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As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 95

Jones Day on

This regular update (no. 95 | 9 January 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 85

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission approves new and amended Member State measures to support the economy - Since the onset of the coronavirus outbreak, the Commission has adopted a significant number...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 80

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission adopts Temporary Crisis Framework to support economy in context of Russia's invasion of Ukraine - On 23 March 2022, the Commission adopted a Communication on a...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 78

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission publishes first Report on implementation of Recovery and Resilience Facility - On 1 March 2022, the Commission published its first Report to the European...more

Morgan Lewis - As Prescribed

Dr. Robert Califf Confirmed to Fill FDA Commissioner Position

Morgan Lewis - As Prescribed on

The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 73

Jones Day on

COMPETITION & STATE AID - Competition - Commission publishes Competition Policy – 2021 at a glance. On 22 December 2021, the European Commission published its Competition Policy – 2021 at a glance. ...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.72

Jones Day on

COMPETITION & STATE AID - Competition- European Commission expresses views on IAG’s (aborted) intended acquisition of Air Europa, including in light of impact of COVID-19 restrictions - On 16 December 2021, the...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 71

Jones Day on

COMPETITION & STATE AID - Competition - Executive Vice President and Competition Commissioner Margrethe Vestager speaks at U.S. Chamber of Commerce's Transatlantic Business Works Summit. ...more

Jones Day

COVID-19 KEY EU Developments, Policy & Regulatory Update No. 70

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission adopts revised Guidelines on State aid to promote risk finance investments- On 6 December 2021, the Commission published its Communication on Guidelines on...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.69

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI). On 25 November 2021, the Commission published a...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 68

Jones Day on

COMPETION & STATE AID - European Commission adopts Communication on a Competition Policy Fit for New Challenges - On 18 November 2021, the European Commission adopted a Communication on a Competition Policy Fit for New...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory update No.67

Jones Day on

COMPETITION & STATE AID - European Commission comments on transatlantic relations in post-pandemic world, including building resilient supply chains - On 12 November 2021, Executive Vice-President and Competition...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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In Tuesday's Report: U.S. Senate to vote on relief package, an analysis of how data protection principles relate to vaccine passports...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 #17

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In Washington: Senate Democrats made their final pitch on Wednesday to Senate Parliamentarian Elizabeth MacDonough to include a minimum wage hike in coronavirus relief legislation. The Parliamentarian decides whether...more

Mintz - Health Care Viewpoints

Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems

Mintz - Health Care Viewpoints on

Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 5

Hogan Lovells on

In Washington: The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S.A. variant of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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In Tuesday's Report: European Commission proposes far-reaching pharmaceutical strategic plan, Biden names health care nominees, and warnings over Christmas COVID-19 spread....more

Hogan Lovells

Coronavirus: The Hill and the Headlines, November 2020 # 12

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In Washington: Wednesday, the House held its leadership elections reelecting Rep. Nancy Pelosi (D-CA) as Speaker of the House by her caucus. Other top Democratic leaders, Majority Leader Steny Hoyer (D-MD) and Majority...more

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