Excipient Qualification Process Set Forth in IPEC Guidelines
This article was originally published in The Gold Sheet
Executive Summary
How to qualify excipients is set forth in new IPEC guidelines.
You may also be interested in...
IPEC Releases Quality Agreement Template for Excipients
IPEC offers template for excipient quality agreements.
COVID Mutants: Vaccine Changes Likely To Need Immunogenicity Studies, Not Big Efficacy Trials
US FDA considering approach that is similar to, but more stringent than, influenza strain changes, CBER Director Marks says. Meanwhile, vaccine developers face challenge of when to change antigens to get the best results, NIH’s Graham notes. As FDA and sponsors gain more experience with tweaking the vaccines to account for new coronavirus variants and strains, the process may be expedited further.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: