Conference Spotlight
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
A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Four
What are some of the product and regulatory challenges companies developing cell and gene therapy (CGT)
A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Three
A fundamental tenet for drug product development is that a clear and deep understanding of the product is
Enforcement
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On July 10, 2023, China’s Center for Drug Evaluation released a draft guidance for a two-week comment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