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Pharmaceutical Industry Food and Drug Administration (FDA) Medical Supplies

McDermott Will & Emery

FDA Gives Companies a New Way to Fight Misinformation

McDermott Will & Emery on

Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more

Knobbe Martens

FDA Issues Updated Informed Consent Guidance for Clinical Investigations

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On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical...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

Alston & Bird

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

Alston & Bird on

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

Morgan Lewis

FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing...

Morgan Lewis on

In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement...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

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 #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

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 #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

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review - May 2021 #3

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In the past week, the FDA authorized the Pfizer/BioNTech COVID-19 vaccine for adolescent use and updated its inspection guidance again. In addition, President Biden announced that the U.S. had reached the 250 million vaccine...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – April 2021 #3

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In the past week, the federal government recommended a pause in the use of Johnson & Johnson’s COVID-19 vaccine due to safety concerns. In addition, the FDA issued the long-awaited guidance on remote interactive evaluations...more

Alston & Bird

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

Alston & Bird on

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

Alston & Bird on

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

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – March 2021 #4

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In the past week, senior FDA officials revealed that the FDA is preparing for more inspections and exploring new inspection technologies. In addition, the Biden Administration announced a loan of AstraZeneca vaccines to...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – March 2021 #3

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In the past week, President Biden signed the American Rescue Plan, which provides $10 billion to expand domestic production of medical supplies. The President also announced that all adults in the U.S. will be eligible for...more

Alston & Bird

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

Alston & Bird on

In the past week, Johnson & Johnson and Merck agreed to cooperate on production of the Janssen vaccine, and the Biden Administration used the Defense Production Act (DPA) to facilitate the arrangement. In addition, the GAO...more

Womble Bond Dickinson

Emergency Use Authorization Issued for COVID-19 Antibody

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On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more

Wilson Sonsini Goodrich & Rosati

FDA Declines to Review Certain EUAs, Raising Reimbursement and Liability Issues

The Food and Drug Administration (FDA or the Agency) announced on October 7 that it will no longer review Emergency Use Authorizations (EUAs) for laboratory developed tests (LDTs). LDTs are a distinct category of in vitro...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

Hogan Lovells on

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

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