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In the past week, the FDA revealed the future plan for its inspectional activities. In addition, President Biden announced a new July 4 vaccination target. Please see details for these and other supply chain developments below:
On April 27, Medtech Insight posted an FDA document to a medical device firm, explaining the Office of Medical Device and Radiological Health Operations’ Remote Regulatory Assessment (RRA) program to determine medical device facilities’ compliance status. Under the RRA program, the FDA requests and discusses electronic documents through meetings with the facilities. Participation in an RRA is voluntary, and refusal to provide information requested during an RRA is not a refusal of an inspection under Section 704 of the Federal Food, Drug, and Cosmetic Act. RRA findings will be considered for future routine FDA workplans and will be a factor in deciding the need for an onsite inspection.
An Update from Federal Officials on Efforts to Combat COVID-19”
10:00 a.m.
May 12
COVID-19 Variants and Evolving Research Needs”
10:00 a.m.
House Energy and Commerce Committee, Subcommittee on Health:
“Hearing on the Fiscal Year 2022 HHS Budget”
10:30 a.m.
Senate Committee on Veterans’ Affairs Hearing: “
Supporting Disabled Veterans: The State of Claims Processing During and After COVID-19”
3:00 p.m.
May 13
House Appropriations Committee, Subcommittee on Departments of Labor, Health and Human Services, Education and Related Agencies Hearing: “
Mental Health Emergencies: Building a Robust Crisis Response System”
10:00 a.m.
For more information, click here.
House Foreign Affairs Committee, Subcommittee on Western Hemisphere, Civilian Security, Migration, and International Economic Policy Hearing: “
COVID-19 Update: FDA Outlines Inspection and Assessment Activities During Pandemic
By Sentinel News Service
Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.
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In March 2020, the FDA announced that it was temporarily postponing all domestic and foreign routine surveillance facility inspections, while continuing mission critical inspections when possible.
Beginning the week of July 20, 2020, the FDA began to work toward resuming prioritized domestic inspections using its COVID-19 Advisory Rating system. The report outlines inspections that the agency was unable to complete during the past year due to travel restrictions or inability to ensure the safety of our workfo
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SILVER SPRING, Md., May 5, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration issued a new report titled, Resiliency Roadmap for FDA Inspectional Oversight, outlining the agency s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA s priorities related to this work going forward. Like most organizations around the world, the FDA experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our inspection, surveillance and compliance activities were significantly impacted, said Acting FDA Commissioner Janet Woodcock, M.D. The FDA fully understands the importance of getting back to a more consistent state of inspectional capacity. This plan provides the public with a transparent picture of both the successes and challenges we ve faced in these areas over the past year, as well as our plan moving forw