Jump-Start 2023 With 2022's Must-Know FDA Guidances On Pharmaceutical Production

The FDA published a number of draft and final guidance documents in 2022. In this e-book, we summarize the most important guidance documents related to pharmaceutical production so that you can start 2023 with a strong understanding of regulatory perspective.

• Quality Metrics Reporting Program
• Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
• Pre-Launch Activities Importation Requests (PLAIR)
• Risk Management Plans to Mitigate the Potential for Drug Shortages
• Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors
• Benefit-Risk Considerations for Product Quality Assessments
• Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production: Level 2 Revision
• Q9(R1) Quality Risk Management
• Conducting Remote Regulatory Assessments: Questions and Answers
• Drug Products, Including Biological Products, that Contain Nanomaterials
• Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, Revision 1
• M10 Bioanalytical Method Validation and Study Sample Analysis

In addition, the final article in the e-book recaps the 2022 guidance documents related to Drug Supply Chain Security Act (DSCSA) implementation. The countdown to full DSCSA implementation in November 2023 has begun!