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Supply Chain Medical Supplies

Braumiller Law Group, PLLC

Hot Topics in International Trade - June 2024- Summary of the Findings of the USTR Four-Year Review of Actions Taken in the...

On May 14, 2024, the United States Trade Representative (USTR) released its Final Report relating to the four-year review of actions taken in the Section 301 investigation. Within the Report, the USTR confirmed that it...more

Knobbe Martens

FDA Updates Medical Device Shortages List

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The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

Hogan Lovells

After the Public Health Emergency: FDA plans to revise COVID-19 EUA policies

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On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect,...more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

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

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

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

FTC to Probe Supply Chain Issues of Major Companies – Medical Products Supply Chain Week in Review

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In the past two weeks, the Federal Trade Commission (FTC) has ordered major U.S. companies to provide information on their supply chain issues and solutions. The FDA issued an emergency use authorization (EUA) for a...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

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

Alston & Bird

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

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Last week, the FDA authorized the booster doses for both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses. The FDA also proposed a new rule for over-the-counter (OTC) hearing aids. The...more

Alston & Bird

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

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Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs. The FDA provided information to the public about a database repository of gene variants and associated conditions....more

Alston & Bird

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

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Last week, the White House COVID-19 Response Team indicated the Administration is ready to begin providing booster vaccine doses to eligible Americans. The FDA alerted clinical laboratory staff and health care professionals...more

Alston & Bird

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

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Last week, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met and provided recommendations on the COVID-19 booster dose, and yesterday the FDA authorized the booster dose for certain...more

Alston & Bird

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

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Over the last two weeks, the President signed Executive Orders requiring all federal employees and contractors to be vaccinated. The White House COVID-19 Response Team announced a $3 billion investment in the vaccine supply...more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #5

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Last week, the White House COVID-19 Response Team encouraged school systems to implement a layered approach to prevention as schools return to in-person learning. Moderna submitted a Biologics License Application (BLA) for...more

McDermott Will & Emery

New Public-Comment Period Regarding Section 301 Tariffs Impacting Certain Medical-Care and COVID-19 Response Products

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As the country continues to experience the effects of the COVID-19 pandemic, the Office of the US Trade Representative (USTR) has invited public comments on whether to continue excluding certain medical supplies from the...more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #4

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Last week, Roche announced a shortage of its drug Actmera/RoActmera, which is used to treat COVID-19. The company, however, does have a mitigation strategy that it plans to implement to lessen the impact. The White House...more

Alston & Bird

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

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Last week, the FDA amended the Moderna and Pfizer-BioNTech emergency use authorizations (EUAs) to allow an additional dose of the mRNA COVID-19 vaccine for immunocompromised individuals. In addition, the Secretaries of...more

Alston & Bird

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

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Last week, the Administration’s COVID-19 Response Team reported that the case numbers continue to rise in low-vaccination states, with most infections as a result of the Delta variant. Vaccination rates, however, are starting...more

Knobbe Martens

FDA Taking Steps to Prevent Future Medical Device Shortages

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The medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic.  Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices. ...more

Alston & Bird

Medical Products Supply Chain Week in Review – July 2021 #4

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Last week, FDA Acting Commissioner Janet Woodcock testified before Congress on the role of the agency in the COVID-19 response and the way forward. The Administration reaffirms its commitment to combat the national and global...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

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