Podcast: President Biden's Use of the Defense Production Act - Diagnosing Health Care
Supporting Health Through Supply Chain Management
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Blakes Continuity Podcast: Life Sciences: Liability and Immunity During COVID-19
K&L Gates Triage: Using Drones in Medicine
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
News Briefs - Biden Places New Tariffs on Chinese Medtech Product Imports - The Biden administration announced its plan to increase tariffs on Chinese-made medical supplies as part of a broader push to tax imports from the...more
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
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
The Medicines and Healthcare products Regulatory Agency has extended the EC Decision reliance procedure (EC DRP) to apply until 31 December 2023....more
This week, North Carolina announced that it will begin long-range health care deliveries by drone in an effort to expand on-demand health care and improve the patient experience in the state. A distribution center will be set...more
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
Zipline, a drone operator and logistics company, plans to partner with Magellan Health’s pharmacy unit to deliver medical prescriptions to homes in Charlotte, North Carolina, this year, helping to jumpstart the era of...more
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
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
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
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
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
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
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
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
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
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
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
The pandemic has spared no industry. As fast-food chains have sought to drive business through chicken sandwich wars, Burger King’s release of its chicken sandwich was delayed in Michigan due to a shortage of pickle jars....more
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
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
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
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
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