2023 US FDA Drug Quality Guidance Expected To Include 20-Year CTD Update, Much More
Executive Summary
A revision of the ICH Common Technical Document expected this year will set the global stage for eventual “structured” quality submissions. Meanwhile, the FDA plans to complete work on ICH impurities guidance and advanced manufacturing technology guidance.
You may also be interested in...
US FDA Expands KASA Platform To Probe API Synthesis, Conduct NDA Quality Reviews
Agency builds on success with last year’s KASA-based ANDA quality reviews to widen and deepen the software tool’s functionality, says CDER OPQ leadership. CMC assessors are adapting quickly to a platform that could soon alert them to issues like possible genotoxic impurity formation during API synthesis.
US Funding Law Could Speed Approval Of Drugs And Biologics Manufactured In Advanced Ways
FY 2023 appropriations language requires HHS Secretary to designate advanced manufacturing technologies for expedited review, and to follow up with advice and meetings that could help move things along.
Revised US Approach For Parenteral Drug Leachables Could Prevent Regulatory Missteps
Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.