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Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding

Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding
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FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities | Alston & Bird

FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities | Alston & Bird
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FDA Inspections Are Changes On The Horizon

FDA Inspections: Are Changes On The Horizon?
By Kalah Auchincloss, SVP & deputy general counsel, Greenleaf Health, Inc.
Almost exactly one year ago, in March 2020, the U.S. FDA announced that it was suspending all foreign and domestic inspections except those it deemed “mission critical.”[1] This unusual move was a response to the then-emerging COVID-19 pandemic an attempt to reduce transmission of the virus and protect both FDA personnel and industry employees.
Even as it suspended inspections, the agency assured the public that it had “full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate.”[2] A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug ....

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FDA's COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers

FDA s COVID-19 PREPP Initiative Summary Report â Key Takeaways For Manufacturers
By Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc.
In January 2021, as one of his last official acts as the Commissioner of the FDA, Stephen Hahn, M.D., published the
FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report.
1 The PREPP report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response spanning FDA policies, processes, operations, communications, and intra-agency coordination to the global COVID-19 pandemic.
2 The FDA asked an independent non-government organization to conduct an objective review of its ongoing COVID-19 response and to summarize findings in the PREPP report. To that end, the third-party organization solicited insights from key FDA staff and external stakeholders, collated lessons learned, ....

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FDA's COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers

FDA's COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers
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