News & Analysis as of

Medical Devices Pharmaceutical Industry Vaccinations

Alston & Bird

Health Care Week in Review: CMS Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor...

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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

Health Care Week in Review: Texas Judge Blocked FTC Rule Banning Noncompetes; Biden Administration Announced $1.4 Billion for HIV...

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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

Health Care Week in Review: State of the Union and HHS Guidance on Drug Rebates and PHE

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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

Harris Beach PLLC

Medical and Life Sciences: Year in Review 2022

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From pharmaceuticals to toothpaste, preemption to public health, New York state and federal courts issued decisions in 2022 that further shaped the landscape in the medical and life sciences legal world. To prepare the best...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Alston & Bird

Alston & Bird Health Care Week in Review - May 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 health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Jones Day

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

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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

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

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In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - January 2022

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Alston & Bird

FDA Suspends Non-Mission-Critical Domestic and Foreign Inspections – Medical Products Supply Chain Week in Review

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Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies - January 2022

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more

Jones Day

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

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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

Alston & Bird

FDA Authorizes Booster Dose for Adolescents – Medical Products Supply Chain Week in Review

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Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11...more

Alston & Bird

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

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In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more

Jones Day

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

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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

Alston & Bird

Pfizer and BioNTech to Request Approval for Vaccine Use in 12-to-15-Year-Olds – Medical Products Supply Chain Week in Review

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In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to seek authorization of the booster dose in...more

Jones Day

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

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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

Alston & Bird

Medical Products Supply Chain Week in Review – FDA Authorizes Pfizer and Moderna Booster for All Adults

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In the past week, the FDA authorized the Pfizer and Moderna booster shots for all adult age groups, while the CDC Advisory Committee on Immunization Practices (ACIP) also recommended the Moderna vaccine booster for all...more

Alston & Bird

Medical Products Supply Chain Week in Review – November 2021 #2

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In the past week, the President has selected Dr. Robert Califf to be FDA commissioner. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements were issued by OSHA and CMS for certain...more

Alston & Bird

Medical Products Supply Chain Week in Review – November 2021 #1

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In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration held a...more

Hogan Lovells

Consultation open: Review of the National Medicines Policy

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The Department of Health (Department) has opened a public consultation on the review of the National Medicines Policy (NMP). As part of the review, the Expert Advisory Committee (Committee) is seeking feedback on a number of...more

Alston & Bird

Medical Products Supply Chain Week in Review – July 2021 #3

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Last week, six U.S. agencies updated an advisory to urge businesses to conduct human rights due diligence for supply chain links to Xinjiang, China. In addition, the Pfizer/BioNTech COVID-19 vaccine received Priority Review...more

Hogan Lovells

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

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA revokes...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – April 2021 #2

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In the past week, President Biden announced a new vaccination progress target, while the Baltimore facility incident affected Johnson & Johnson’s vaccine delivery. In addition, the FDA issued a guidance document regarding...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – March 2021 #5

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In the past week, the Suez Canal blockage has shaken the global supply chain. In the U.S., more than 27 million doses of COVID-19 vaccines were distributed, and AstraZeneca responded to concerns over its COVID-19 vaccine...more

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