Drug GMP Warning Letter Issued Without Facility Inspection
Are there high-risk drugs on the market that do not require an FDA drug application submission, approval,
Looking Outside Your Four Walls at GMP by the Sea
It’s challenging enough to use Quality Management Maturity (QMM) within your own facility, and keeping
FDA Post-Warning Letter Meetings are Not Agency Consultations
After receiving an FDA warning letter, eligible generic drug firms now have the option of scheduling a
Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies
In Part 1 of this article, we explored FDA’s policy on reviewing internal audit reports as outlined in
Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”
On July 10, 2023, China’s Center for Drug Evaluation released a draft guidance for a two-week comment
Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)
FDA Site Selection Model Updated to Include Regional Risk Factors A late-June 2023 update to FDA’s
Trends & Analysis
How Redica Systems Goes Further than the FDA Data Dashboard
Note: The data provided in this post was gathered in July 2023. Compared to other global
Redica Responds: What are Common Laboratory Inspection Findings?
Redica Responds is an article series where we take common/unique questions from customers and industry
Is Raw FDA Data Skewing Your Analyses?
Which GMP quality system was most often linked to FDA drug recalls since 2012? Redica’s Jerry
Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
In Part 4 of our series on virtual agency inspections, former FDA investigator Ricki Chase provides her advice on how to host a virtual inspection, including best practices, how to adjust your logistics, and how to prepare for a closeout meeting.