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Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

Bill of Health

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes , creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development. By Aparajita Lath. However, some suggest that patents are impeding access to research. 3d 1351 (Fed.

COVID-19 173
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Pharmacy Interoperability Challenges and Needs Under the 21st Century Cures Act

HIT Consultant

4 As the most accessible healthcare providers, especially in medically underserved and rural areas, pharmacists most recently played a crucial role in helping the nation combat COVID-19 through administering vaccines, testing, and therapeutics. Community Pharmacists’ Contributions to Disease Management During the COVID-19 Pandemic.”

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SQA Regulatory Surveillance Summary 1 | Monthly Update 2021

SQA

NMPA Adjusts Classification Catalog and Down-Classifies Some Medical Devices, 19 January 2021. China’s UDI pilot program wrapped up at the close of 2020; it was previously slated to end in October, but the NMPA extended this trial period due to the impact of the COVID-19 pandemic. China Guidances and Regulations.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

SQA

ANVISA published the RDC 702/2022, which repeals some requirements that were instituted to speed market approval of devices needed to treat patients during the height of the COVID-19 pandemic. The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. 27 May 2022.

FDA 91
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

19 Medical Rehabilitation Equipment. This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells. CMDE Announcement No. 04 Orthopedic Surgical Instruments. 07 Medical Diagnostic and Monitoring Equipment. 08 Respiration, Anesthesia and First Aid Devices.

FDA 40
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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. This guidance replaces the industry guidelines entitled Policy for Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19), which was published in January 2021.

FDA 52
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A Texas Mess

Drug & Device Law

So we do have comments on the bizarre complaint that the Texas attorney general recently filed over COVID-19. The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. 2002); Tracker Marine, L.P. 3d 675, 698 (Tex.