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USFDA Q&A Guidance: Remote Regulatory Assessments (RRA) and Guidance on Antibacterial Therapies (Q&A) and Early Lyme Disease
The U.S. Food and Drug Administration (FDA) has finalized its guidance document on " Conducting Remote Regulatory Assessments (RRAs) ,"...
Sharan Murugan
Jun 29, 20252 min read
PIC/S Guidance: Remote Assessments for GMP Inspections
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released its " Guidance on Remote Assessments " effective from January...
Sharan Murugan
Jan 11, 20252 min read
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...
Sharan Murugan
Jan 28, 20242 min read